Systemic Immune-Inflammation Index in Relation to Diabetes Markers in Saudi Adults: A Retrospective Study.

Background and objectives: Low-grade inflammation is associated with metabolic disturbances like diabetes. The systemic immune-inflammation index (SII) has been proposed as a predictive tool to identify individuals at a greater risk of diabetes. This study aims to examine the association between SII and diabetes markers. Method and materials: We used retrospective data from a large cohort of adults (n = 3895) aged ≥18 in Saudi Arabia. The SII was calculated, and the markers of diabetes such as fasting blood glucose (FBG), insulin, and hemoglobin A1c (HbA1c) were included. Results: Across the quartiles of SII, FBG, insulin, and HbA1c were significantly higher in adults with higher compared to lower SII (p < 0.0001, p = 0.04, p < 0.0001, respectively). A two SD higher FBG was significantly associated with an SII difference of 47.7 (95% CI: (15.5, 91.9)). In subgroup analysis, this relationship prevailed in normal-weight participants and among those with normoglycemia and prediabetes but was attenuated in participants with diabetes. The association also prevailed in separate analyses for males and females but was stronger among females. Linear regression models showed no significant association between insulin, HbA1c, and SII. Conclusions: SII was associated with the markers of diabetes. The utility of SII for predicting diabetes can be confirmed with prospective cohort studies.

Tripeptide gut hormone infusion does not alter food preferences or sweet taste function in volunteers with obesity and prediabetes/diabetes but promotes restraint eating: A secondary analysis of a randomized single-blind placebo-controlled study.

AIMS: To investigate whether the elevation in postprandial concentrations of the gut hormones glucagon-like peptide-1 (GLP-1), oxyntomodulin (OXM) and peptide YY (PYY) accounts for the beneficial changes in food preferences, sweet taste function and eating behaviour after Roux-en-Y gastric bypass (RYGB). MATERIALS AND METHODS: This was a secondary analysis of a randomized single-blind study in which we infused GLP-1, OXM, PYY (GOP) or 0.9% saline subcutaneously for 4 weeks in 24 subjects with obesity and prediabetes/diabetes, to replicate their peak postprandial concentrations, as measured at 1 month in a matched RYGB cohort (ClinicalTrials.gov NCT01945840). A 4-day food diary and validated eating behaviour questionnaires were completed. Sweet taste detection was measured using the method of constant stimuli. Correct sucrose identification (corrected hit rates) was recorded, and sweet taste detection thresholds (EC50s: half maximum effective concencration values) were derived from concentration curves. The intensity and consummatory reward value of sweet taste were assessed using the generalized Labelled Magnitude Scale. RESULTS: Mean daily energy intake was reduced by 27% with GOP but no significant changes in food preferences were observed, whereas a reduction in fat and increase in protein intake were seen post-RYGB. There was no change in corrected hit rates or detection thresholds for sucrose detection following GOP infusion. Additionally, GOP did not alter the intensity or consummatory reward value of sweet taste. A significant reduction in restraint eating, comparable to the RYGB group was observed with GOP. CONCLUSION: The elevation in plasma GOP concentrations after RYGB is unlikely to mediate changes in food preferences and sweet taste function after surgery but may promote restraint eating.

Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to examine the clinical efficacy and safety of the duodenal-jejunal bypass liner (DJBL) while in situ for 12 months and for 12 months after explantation. SUMMARY BACKGROUND DATA: This is the largest randomized controlled trial (RCT) of the DJBL, a medical device used for the treatment of people with type 2 diabetes mellitus (T2DM) and obesity. Endoscopic interventions have been developed as potential alternatives to those not eligible or fearful of the risks of metabolic surgery. METHODS: In this multicenter open-label RCT, 170 adults with inadequately controlled T2DM and obesity were randomized to intensive medical care with or without the DJBL. Primary outcome was the percentage of participants achieving a glycated hemoglobin reduction of ≥20% at 12 months. Secondary outcomes included weight loss and cardiometabolic risk factors at 12 and 24 months. RESULTS: There were no significant differences in the percentage of patients achieving the primary outcome between both groups at 12 months [DJBL 54.6% (n = 30) vs control 55.2% (n = 32); odds ratio (OR) 0.93, 95% confidence interval (CI): 0.44-2.0; P = 0.85]. Twenty-four percent (n = 16) patients achieved ≥15% weight loss in the DJBL group compared to 4% (n = 2) in the controls at 12 months (OR 8.3, 95% CI: 1.8-39; P = .007). The DJBL group experienced superior reductions in systolic blood pressure, serum cholesterol, and alanine transaminase at 12 months. There were more adverse events in the DJBL group. CONCLUSIONS: The addition of the DJBL to intensive medical care was associated with superior weight loss, improvements in cardiometabolic risk factors, and fatty liver disease markers, but not glycemia, only while the device was in situ. The benefits of the devices need to be balanced against the higher rate of adverse events when making clinical decisions. TRIAL REGISTRATION: ISRCTN30845205. isrctn.org; Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership reference 12/10/04.

The Relationships between Various Factors and Sleep Status: A Cross-Sectional Study among Healthy Saudi Adults.

Impaired sleep can adversely affect daily life. This study assesses the association between different factors and sleep status among apparently healthy Saudi adults. In total, 478 adults were included in this study. Data on anthropometrics, body composition, stress scales, physical activity, and dietary habits were collected. Fasting blood glucose and lipid profile were measured. Sleep quality and duration were assessed using the Pittsburgh Sleep Quality Index. Larger neck circumference (NC) was associated with short sleep duration (odds ratio (OR) 1.23; 95% confidence interval (CI) [1.08, 1.41]; p = 0.002). Higher triglyceride levels were associated with poor sleep quality (OR 1.01; 95% CI [1.002, 1.02]; p = 0.019) and short sleep duration (OR 1.01; 95% CI [1.004, 1.02]; p = 0.005). Stress was a risk factor for poor sleep quality (OR 1.15; 95% CI [1.09, 1.22]; p < 0.001). Being married was significantly associated with good sleep quality (OR 2.97; 95% CI [1.32, 6.71]; p = 0.009), while being single was correlated with longer sleep duration (OR 0.46; 95% CI [0.22, 0.96]; p = 0.039). Other factors such as having a larger waist circumference and more muscle mass were protective factors against poor sleep quality and/or short sleep duration. In conclusion, a larger NC is suggested as a risk factor for short sleep duration and a higher triglyceride level for both short and poor sleep among healthy Saudis. Investigating the factors associated with sleep status may help alleviate sleep disturbances and improve overall health. Further studies are needed to confirm causality using objective sleep measures.

Metagenomic Shotgun Sequencing Reveals Specific Human Gut Microbiota Associated with Insulin Resistance and Body Fat Distribution in Saudi Women.

(1) Background: Gut microbiota dysbiosis may lead to diseases such as insulin resistance and obesity. We aimed to investigate the relationship between insulin resistance, body fat distribution, and gut microbiota composition. (2) Methods: The present study included 92 Saudi women (18-25 years) with obesity (body mass index (BMI) ≥ 30 kg/m2, n = 44) and with normal weight (BMI 18.50-24.99 kg/m2, n = 48). Body composition indices, biochemical data, and stool samples were collected. The whole-genome shotgun sequencing technique was used to analyze the gut microbiota. Participants were divided into subgroups stratified by the homeostatic model assessment for insulin resistance (HOMA-IR) and other adiposity indices. (3) Results: HOMA-IR was inversely correlated with Actinobacteria (r = -0.31, p = 0.003), fasting blood glucose was inversely correlated with Bifidobacterium kashiwanohense (r = -0.22, p = 0.03), and insulin was inversely correlated with Bifidobacterium adolescentis (r = -0.22, p = 0.04). There were significant differences in α- and ß-diversities in those with high HOMA-IR and waist-hip ratio (WHR) compared to low HOMA-IR and WHR (p = 0.02, 0.03, respectively). (4) Conclusions: Our findings highlight the relationship between specific gut microbiota at different taxonomic levels and measures of glycemic control in Saudi Arabian women. Future studies are required to determine the role of the identified strains in the development of insulin resistance.

Shared and Distinct Gut Microbial Profiles in Saudi Women with Metabolically Healthy and Unhealthy Obesity.

BACKGROUND: Mounting evidence suggests a pivotal role for the gut microbiome in energy disequilibrium characteristic of obesity. The clinical utility of microbial profiling for the distinction between metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUO) remains ill-defined. We aim to probe microbial composition and diversity in young adult Saudi females with MHO and MUO. This observational study included anthropometric and biochemical measurements and shotgun sequencing of stool DNA for 92 subjects. α- and ß-diversity metrics were calculated to determine the richness and variability in microbial communities, respectively. Results showed that Bacteroides and Bifidobacterium merycicum were less abundant in MUO compared to healthy and MHO groups. BMI was negatively correlated with B. adolescentis, B. longum, and Actinobacteria in MHO, while being positively correlated with Bacteroides thetaiotaomicron in both MHO and MUO. Positive correlations between waist circumference and B. merycicum and B. thetaiotaomicron were observed in MHO and MUO, respectively. Compared to MHO and MUO groups, higher α-diversity was detected in healthy individuals who also had higher ß-diversity compared to those with MHO. We conclude that modulation of the gut microbiome cohorts through prebiotics, probiotics, and fecal microbiota transplantation may be a promising preventive and therapeutic approach to obesity-associated disease.

The Efficacy of GLP-1 Analogues on Appetite Parameters, Gastric Emptying, Food Preference and Taste Among Adults with Obesity: Systematic Review of Randomized Controlled Trials.

Background: Obesity is an epidemiological issue that negatively affects public health and has led to a high global burden on the healthcare system. Several approaches to control and overcome the obesity crisis have been established. However, Nobel discoverers found that glucagon-like peptide-1 analogues (GLP-1 analogues) positively regulate appetite and food intake, eventually leading to weight loss. Objective: The present systematic review aims to summarize the currently available evidence of the impact of GLP-1 analogues on appetite, gastric emptying, taste sensitivity, and food preferences among adults with obesity without other chronic diseases. Methods: A systematic literature search was conducted from October 2021 to December 2021 from three electronic databases (PubMed, Scopus, and ScienceDirect), including only randomized clinical trials (RCTs). Studies were based on the use of GLP-1 analogues, of any dosage and duration among adults with obesity without other medical diseases; studies measured appetite, gastric emptying, food preferences, and taste as a primary or secondary outcome. The risk of publication bias in each study was assessed independently using the updated Cochrane risk-of-bias tool (RoB2). Results: Twelve studies met the inclusion criteria with a total sample size of 445 participants. All the included studies measured at least one or more of the primary outcomes. The promising effect was evidenced by most studies showing appetite suppression, delayed gastric emptying, and changes in taste and food preferences. Conclusion: GLP-1 analogues are effective obesity management therapy that could decrease food intake and eventually reduce weight by suppressing appetite, reducing hunger, decreasing gastric emptying, and altering food preferences and taste. However, high-quality, long-term, large sample size studies are crucial to examine the efficacy and effective dose of GLP-1 analogues intervention.

Translation and Validation of the Arabic Version of the Eating Behavior After Bariatric Surgery (EBBS) Questionnaire.

PURPOSE: Complications after metabolic and bariatric surgery are common due to the patient's poor commitment to postoperative lifestyle changes. Therefore, intensive follow-up from a multidisciplinary team might improve outcomes. The present study aimed to translate and validate the Eating Behavior after Bariatric Surgery (EBBS) questionnaire into Arabic for use in clinical and research settings. MATERIALS AND METHODS: The study followed World Health Organization guidelines for translation and questionnaire adaptation, including forward translation, back translation, pilot testing, and the creation of the final version of the tool. A total of 390 patients who had undergone metabolic and bariatric surgery 3 years ago or more were involved in testing the questionnaire's validity and reliability. RESULTS: The mean age of participants was 36 years (range: 20 to 70 years), 56% were females, 94.1% were Saudis, and 56% had bachelor's degrees. The internal consistency of the questionnaire was tested using Cronbach's alpha. One item (alcohol consumption) was excluded during the reliability analysis due to low variance. The reliability analysis results showed that the 10 items were internally consistent, with a Cronbach's α of 0.851. CONCLUSION: The validation and reliability of the Arabic-language version of the EBBS questionnaire were found to be satisfactory. The presence of a validated Arabic version of this instrument may help practitioners estimate patients' adherence to dietary and lifestyle recommendations after metabolic and bariatric surgery. Furthermore, the questionnaire may aid in identifying factors that influence the efficacy of these procedures.

The Arabic Version of the Adult Eating Behavior Questionnaire among Saudi Population: Translation and Validation.

Inherited individual differences in eating behaviors known as "appetitive traits" can be measured using the Adult Eating Behavior Questionnaire (AEBQ). The AEBQ can be used to assess individuals that require intervention regarding their weight, eating habits, and for the identification of eating disorders. Arabic eating behavior assessment tools are few. This study, therefore, aimed to translate and validate the AEBQ in Arabic language (AEBQ-Ar) and to confirm the factor structure while assessing the internal consistency of all subscales. Participants completed the AEBQ-Ar and reported their sociodemographic data online. Exploratory factor analysis (EFA) was used and internal reliability was assessed using Cronbach's α. Correlations between AEBQ-Ar subscales and body mass index (BMI) were done using Pearson's correlation. A sample of 596 adults, mean age of 35.61 ± 12.85 years, was recruited from Saudi Arabia. The 6-factor structure was the best model, excluding emotional under- eating subscale and merging enjoyment of food and food responsiveness subscales. Internal consistency was acceptable for all subscales (Cronbach's α = 0.89-0.66). Emotional over- eating was positively associated with BMI, and slowness in eating was negatively associated with BMI. The AEBQ-Ar with 6-subscales appears to be a valid and reliable psychometric questionnaire to assess appetitive traits in Arabic speakers.

Does Bypass of the Proximal Small Intestine Impact Food Intake, Preference, and Taste Function in Humans? An Experimental Medicine Study Using the Duodenal-Jejunal Bypass Liner.

The duodenal-jejunal bypass liner (Endobarrier) is an endoscopic treatment for obesity and type 2 diabetes mellitus (T2DM). It creates exclusion of the proximal small intestine similar to that after Roux-en-Y Gastric Bypass (RYGB) surgery. The objective of this study was to employ a reductionist approach to determine whether bypass of the proximal intestine is the component conferring the effects of RYGB on food intake and sweet taste preference using the Endobarrier as a research tool. A nested mechanistic study within a large randomised controlled trial compared the impact of lifestyle modification with vs. without Endobarrier insertion in patients with obesity and T2DM. Forty-seven participants were randomised and assessed at several timepoints using direct and indirect assessments of food intake, food preference and taste function. Patients within the Endobarrier group lost numerically more weight compared to the control group. Using food diaries, our results demonstrated similar reductions of food intake in both groups. There were no significant differences in food preference and sensory, appetitive reward, or consummatory reward domain of sweet taste function between groups or changes within groups. In conclusion, the superior weight loss seen in patients with obesity and T2DM who underwent the Endobarrier insertion was not due to a reduction in energy intake or change in food preferences.

Lifestyle changes associated with COVID-19 quarantine among young Saudi women: A prospective study.

BACKGROUND: Negative lifestyle behaviors are associated with an increased risk of adverse outcomes from coronavirus disease (COVID-19). This study aimed to assess lifestyle changes affecting weight, sleep, mental health, physical activity, and dietary habits prospectively from before COVID-19 to during lockdown. METHODS: A total of 297 Saudi women, aged 19-30 years (mean age, 20.7 ± 1.4 years), were interviewed at two time points, before and during the quarantine. The data collected included anthropometrics, sociodemographic data, clinical history, food frequency questionnaire responses, Pittsburgh Sleep Quality Index scores, Global Physical Activity Questionnaire (GPAQ) responses, and Perceived Stress Scale measures. In addition, during quarantine, COVID-19 and nutrition-related information and Generalized Anxiety Disorder-7 and Patient Health Questionnaire-9 scores were collected. Multivariate multinomial logistic regression analysis was used to examine the indicators of weight gain and loss from before COVID-19 (baseline) until during lockdown. RESULTS: Although approximately half of the participants did not report a weight change, 30% revealed weight loss and 18%, weight gain. The variables associated with increased weight gain were self-quarantine since COVID-19 started (OR: 5.17, 95% CI: 1.57-17.01, p = 0.007), age (OR: 1.53, 1.03-2.28, p = 0.04), and stress at baseline and during lockdown (OR: 1.15, 1.03-1.29, p = 0.01; OR: 1.10, 1.01-1.19, p = 0.03, respectively). The variables associated with a reduced risk of weight gain were the GPAQ score during lockdown (OR: 0.16, 0.04-0.66, p = 0.01), coffee consumption (OR: 0.36, 0.19-0.67, p = 0.01), and total sleep time (OR: 0.70, 0.51-0.97, p = 0.03). CONCLUSION: While most young Saudi women experienced no weight change during the COVID-19 lockdown, one-third lost weight and a significant proportion gained weight. Factors associated with weight, such as stress, sleep hours, physical activity, and coffee consumption, highlight the need to carefully consider those at risk during future circumstances that may require lockdowns. These factors could also aid in implementing policies for future lockdowns and support those most at risk of gaining weight.

The effect of a duodenal-jejunal bypass liner on lipid profile and blood concentrations of long chain polyunsaturated fatty acids.

BACKGROUND & AIMS: Duodenal-jejunal bypass liners (DJBLs) prevent absorption in the proximal small intestine, the site of fatty acid absorption. We sought to investigate the effects of a DJBL on blood concentrations of essential fatty acids (EFAs) and bioactive polyunsaturated fatty acids (PUFAs). METHODS: Sub-study of a multicentre, randomised, controlled trial with two treatment groups. Patients aged 18-65 years with type-2 diabetes mellitus and body mass index 30-50 kg/m2 were randomised to receive a DJBL for 12 months or best medical therapy, diet and exercise. Whole plasma PUFA concentrations were determined at baseline, 10 days, 6 and 11.5 months; data were available for n = 70 patients per group. RESULTS: Weight loss was significantly greater in the DJBL group compared to controls after 11.5 months: total body weight loss 11.3 ± 5.3% versus 6.0 ± 5.7% (mean difference [95% CI] = 5.27% [3.75, 6.80], p < 0.001). Absolute concentrations of both EFAs, linoleic acid and α-linolenic acid, and their bioactive derivatives, arachidonic acid, eicosapentaenoic acid, docosapentaenoic acid and docosahexaenoic acid, were significantly lower in the DJBL group than in the control group at 6 and 11.5 months follow-up. Total serum cholesterol, LDL-cholesterol and HDL-cholesterol were also significantly lower in the DJBL group. CONCLUSION: One year of DJBL therapy is associated with superior weight loss and greater reductions in total serum cholesterol and LDL-cholesterol, but also depletion of EFAs and their longer chain derivatives. DJBL therapy may need to be offset by maintaining an adequate dietary intake of PUFAs or by supplementation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02459561.

Adjunctive liraglutide treatment in patients with persistent or recurrent type 2 diabetes after metabolic surgery (GRAVITAS): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Many patients with type 2 diabetes do not achieve sustained diabetes remission after metabolic (bariatric) surgery for the treatment of obesity. Liraglutide, a glucagon-like peptide-1 analogue, improves glycaemic control and reduces bodyweight in patients with type 2 diabetes. Our aim was to assess the safety and efficacy of liraglutide 1·8 mg in patients with persistent or recurrent type 2 diabetes after metabolic surgery. METHODS: In the GRAVITAS randomised double-blind, placebo-controlled trial, we enrolled adults who had undergone Roux-en-Y gastric bypass or vertical sleeve gastrectomy and had persistent or recurrent type 2 diabetes with HbA1c levels higher than 48 mmol/mol (6·5%) at least 1 year after surgery from five hospitals in London, UK. Participants were randomly assigned (2:1) via a computer-generated sequence to either subcutaneous liraglutide 1·8 mg once daily or placebo, both given together with a reduced-calorie diet, aiming for a 500 kcal per day deficit from baseline energy intake, and increased physical activity. The primary outcome was the change in HbA1c from baseline to the end of the study period at 26 weeks, assessed in patients who completed the trial. Safety was assessed in the safety analysis population, consisting of all participants who received either liraglutide or placebo. This trial is registered with EudraCT, number 2014-003923-23, and the ISRCTN registry, number ISRCTN13643081. FINDINGS: Between Jan 29, 2016, and May 2, 2018, we assigned 80 patients to receive either liraglutide (n=53) or placebo (n=27). 71 (89%) participants completed the study and were included in the principal complete-cases analysis. In a multivariable linear regression analysis, with baseline HbA1c levels and surgery type as covariates, liraglutide treatment was associated with a difference of -13·3 mmol/mol (-1·22%, 95% CI -19·7 to -7·0; p=0·0001) in HbA1c change from baseline to 26 weeks, compared with placebo. Type of surgery had no significant effect on the outcome. 24 (45%) of 53 patients assigned to liraglutide and 11 (41%) of 27 assigned to placebo reported adverse effects: these were mainly gastrointestinal and in line with previous experience with liraglutide. There was one death during the study in a patient assigned to the placebo group, which was considered unrelated to study treatment. INTERPRETATION: These findings support the use of adjunctive liraglutide treatment in patients with persistent or recurrent type 2 diabetes after metabolic surgery. FUNDING: JP Moulton Foundation.