Postbariatric hypoglycemia, abdominal pain and gastrointestinal symptoms after Roux-en-Y gastric bypass explored by continuous glucose monitoring.

BACKGROUND: Abdominal pain and postbariatric hypoglycemia (PBH) are common after bariatric surgery. OBJECTIVES: This study aimed to explore the potential relationship between abdominal pain, gastrointestinal symptoms, and PBH more than a decade after Roux-en-Y gastric bypass (RYGB) and whether continuous glucose monitoring (CGM) with dietary intervention has an educational role in reducing symptoms. SUBJECTS: At two public hospitals in Norway (one University Hospital) 22 of 46 invited patients who reported abdominal pain more than weekly took part. Recruited from a prospective follow-up study of 546 patients 14.5 years after RYGB. METHODS: They used a CGM for two 14-day periods, with a dietary intervention between periods. The Gastrointestinal Symptom Rating Scale (GSRS) and the Dumping Severity Score (DSS) questionnaires were completed at the start and end of the study. RESULTS: The 22 women had preoperative age 39.6 ± 7.7 years and body mass index (BMI) 42.0 ± 4.0 kg/m2, present age 54.6 ± 7.7 years and BMI 29.8 ± 4.8 kg/m2. The total GSRS score and DSS of early dumping decreased after the diet intervention. The number of events with Level 1 (<3.9 mmol/L) or Level 2 (<3.0 mmol/L) hypoglycemia did not change in the second period. Half of the patients had fewer, three had unchanged, and eight had more frequent events with Level 1 hypoglycemia after the intervention. Ten patients had Level 2 hypoglycemia. CONCLUSION: Though inconclusive findings, a personalized dietary intervention reduces GSRS. This intervention was accompanied by lower mean absolute glucose in patients with recurrent abdominal pain after bariatric surgery. However, further studies are needed to explore the benefits of CGM in this setting.

Vitamin and Mineral Deficiency 12 Years After Roux-en-Y Gastric Bypass a Cross-Sectional Multicenter Study.

PURPOSE: Micronutrient deficiencies are common after Roux-en-Y gastric bypass (RYGB). This study explores whether vitamin and mineral deficiency was associated with adherence to recommended supplementation 12 years after RYGB. MATERIALS AND METHODS: The cross-sectional Bariatric Surgery Observation Study (BAROBS) was conducted in 2018-2020 at three hospitals in Central Norway. We report data on 490 patients' self-reported adherence to recommended supplements and vitamin and mineral levels in the blood. The patients, who had RYGB between 2003 and 2009, were recommended an over-the-counter multivitamin-mineral supplement, calcium/vitamin D (1000 mg/20 µg) and vitamin B12 injections (reimbursed), since bariatric supplements were not available then. RESULTS: Mean (SD) age was 40.1 ± 9 years at RYGB, and time to follow-up 11.7 ± 1.6 years. Of 490 patients, 393 (80%) were women. Among 361 (74%) patients' adherent to multivitamin-mineral supplements; folate, vitamin B2, and vitamin B6 deficiency were present in 39 (11%), 103 (29%), and 63 (17%) patients, respectively. The same deficiencies occurred in 44 (34%), 67 (52%), and 67 (52%) patients' non-adherent to recommendations. Although 466 (95%) patients reported adherence to vitamin B12 supplements, sub-optimal levels were found in 73 (16%) patients. Though 336 (69%) patients adhered to calcium/vitamin D supplements (1000 mg/20 µg), sub-optimal vitamin D levels (< 75 nmol/l) were found in 174/336 (52%) adherent patients and 120/154 (78%) non-adherent patients. CONCLUSION: Twelve years after RYGB, adherence to supplements, though in sub-optimal doses of new recommendations, decreases the probability of vitamin and mineral deficiency, especially for thiamine, vitamin B2, vitamin B6, folate, vitamin B12, and vitamin D, but does not eliminate it.

How Did People with Prediabetes Who Attended the Diabetes Prevention Education Program (DiPEP) Experience Making Lifestyle Changes? A Qualitative Study in Nepal.

Diabetes can be prevented through lifestyle modification in the prediabetic phase. A group-based lifestyle intervention called 'Diabetes Prevention Education Program' (DiPEP) was tested recently in Nepal. The present study aimed to explore experiences of making lifestyle changes among people with prediabetes participating in the DiPEP. This qualitative study, with semi-structured interviews of 20 participants, was conducted 4-7 months following DiPEP intervention. Data analysis was performed by thematic analysis. The results included four themes, understanding that diabetes could be prevented, lifestyle changes made, hurdles to overcome, and experiencing benefits leading to sustained change. Some participants said they felt relieved to know that they had a chance to prevent diabetes. The participants talked mostly about making changes in diet (reducing carbohydrate intake) and physical activity (starting exercises). Obstacles mentioned included a lack of motivation and a lack of family support to implement changes. Experiencing benefits such as weight loss and reduced blood sugar levels were reported to lead them to maintain the changes they had made. Understanding that diabetes could be prevented was a key motivator for implementing changes. The benefits and hurdles experienced by the participants of the present study can be taken into consideration while designing lifestyle intervention programs in similar settings.

Factors Associated with Medication Adherence among Patients with Type 2 Diabetes Mellitus: A Hospital-Based Cross-Sectional Study in Nepal.

As diabetes increases globally, high mortality increases due to complications of uncontrolled sugar. Medication adherence is important to control blood sugar and prevent its complications. Objective of the study was to identify factors associated with medication adherence among type 2 diabetes patients. A cross-sectional study was conducted among 343 patients visiting Dhulikhel Hospital, Nepal, for their fasting blood sugar test from September to December 2016. Inclusion criteria: patients with type 2 diabetes, under diabetes medication for past three months (minimum), age ≥ 18 years. The outcome of the study was medication adherence measured using the eight-item Morisky medication adherence scale (MMAS-8) (© 2006 Donald E. Morisky). Multivariate logistic regression was used for the analysis. Results showed that 61% of respondents had high medication adherence; adherence was positively associated with formal education [AOR: 2.43 (95% CI: 1.34, 4.39)] and attendance at diabetes counseling [AOR: 1.76 (95% CI: 1.02, 3.04)] after adjusting for age, occupation, medicine intake duration and diabetes medicine types. The study concluded that formal education and attendance at diabetes counseling positively affected patients' adherence to medicine. We encourage healthcare institutions to provide counseling services to all the patients with type 2 diabetes and focus more on those who are less educated.

Prevalence of prediabetes and associated factors of prediabetic stages: a cross-sectional study among adults in Nepal.

OBJECTIVES: To estimate the prevalence of prediabetes and to assess the association of prediabetic stages with sociodemographic, lifestyle and clinical factors DESIGN: Cross-sectional study at the screening and inclusion stage of a Diabetes Prevention Education Program (DiPEP) trial SETTING: The study was conducted in two urban communities in Nepal (October 2019-March 2020). PARTICIPANTS: A total of 6222 residents of two study sites, aged 18-64 years and without a history of diabetes, were eligible for prediabetes screening. Exclusion criteria were pregnancy, history of diabetes and critical illness. A total of 291 participants with prediabetes were included in this study. PRIMARY AND SECONDARY OUTCOME MEASURES: Prevalence of prediabetes based on glycated haemoglobin (HbA1c) criteria (5.7%-6.4%) was the primary outcome of the study. Odds Ratio and 95% CI were estimated to assess the associations between the outcome prediabetic stages (5.7%-5.9% vs 6.0%-6.4%) and sociodemographic, lifestyle and clinical factors in both unadjusted and adjusted models. RESULTS: Out of 6222 screened participants, 308 (5%, 95% CI: 4.4% to 5.5%) individuals were detected with prediabetes based on HbA1c. The mean age of 291 responded participants was 50.3±7.6 years and 67% were females. Among them, 78% aged 45-64 years, 97% had central obesity, 90% had high waist-hip ratio, 63% were hypertensive and 66% had no family history of diabetes. Approximately, 54% and 46% of individuals with prediabetes had HbA1c of 5.7%-5.9% and 6.0%-6.4%, respectively. Female gender was associated with prediabetes with HbA1c 6.0%-6.4% (OR, 1.98, 95% CI: 1.07 to 3.67) in the adjusted model. CONCLUSION: The estimated prevalence of prediabetes was 5% among screened participants, and female gender was associated with the prediabetic stage. As a large proportion of the population with prediabetes were not aware of their status, this study demonstrates a need for regular community screening programmes to detect individuals with prediabetes and provide them a comprehensive lifestyle intervention for diabetes prevention. TRIAL REGISTRATION NUMBER: NCT04074148, 2019/783.

The Long-Term Impact of Postoperative Educational Programs on Weight Loss After Roux-en-Y Gastric Bypass.

PURPOSE: Roux-en-Y gastric bypass (RYGB) is a well-documented treatment of severe obesity. Attending postoperative educational programs may improve the outcome. The aim of this study was to evaluate whether participation in educational programs lasting 2-3 years after RYGB influences long-term weight loss, weight regain, physical activity, and compliance to multivitamin supplements. MATERIALS AND METHODS: The Bariatric Surgery Observation Study (BAROBS) is a multicenter retrospective, cross-sectional study 10-15 years after primary RYGB. Four hundred and ninety-seven participants answered questions regarding participation in postoperative educational programs. Participants were divided into frequent attendees (FA) and infrequent attendees (IFA) at the educational programs. RESULTS: Ten to 15 years after surgery, a total weight loss (TWL) of 23.2 ± 11.6% were seen in the FA group vs 19.5 ± 12.6% in the IFA group, p < 0.001. Percent excess weight loss (%EWL) was 55.7 ± 28.9% vs 46.0 ± 31.1%, p < 0.001. Weight regain in percent of maximal weight loss for the FA was 32.1 ± 32.8% vs IFA 38.4 ± 40.0%, p = 0.052. No difference between the groups in compliance to multivitamin and physical activity. CONCLUSION: Participants with frequent participation in group-based educational programs had better weight loss outcomes 10-15 years after RYGB and tended to have less weight regain. There was no difference between the two groups in participants compliance to recommended multivitamin supplements and physical activity.

Diabetes Prevention Education Program in a population with pre-diabetes in Nepal: a study protocol of a cluster randomised controlled trial (DiPEP).

INTRODUCTION: Evidence suggests that diabetes burden can be reduced by implementing early lifestyle intervention programmes in population with pre-diabetes in high-income countries. However, little is known in developing nations like Nepal. This study aims to assess effectiveness of community-based Diabetes Prevention Education Program (DiPEP) on haemoglobin A1c (HbA1c) level, proportion of pre-diabetes reverting to normoglycaemia, diet, physical activity, weight reduction, diabetes knowledge and health literacy after 6 months of follow-up. Furthermore, we will also conduct qualitative studies to explore experiences of participants of intervention sessions and perception of healthcare workers/volunteers about DiPEP. METHODS AND ANALYSES: This is a community-based two-arm, open-label, cluster randomised controlled trial. We will randomise 14 clusters into intervention arm and control arm. Estimated total sample size is 448. We will screen individuals without diabetes, aged 18-64 years, and permanent residents of study sites. HbA1c test will be only performed if both Indian Diabetes Risk Score and random blood sugar value are ≥60 and 140-250 mg/dL, respectively. At baseline, participants in intervention arm will receive DiPEP package (including intensive intervention classes, diabetes prevention brochure, exercise calendar and food record booklet), and participants in control arm will be provided only with diabetes prevention brochure. The change in outcome measures will be compared between intervention to control arm after 6 months of follow-up by linear mixed models. Also, we will conduct individual interviews among participants and healthcare workers as part of a qualitative study. We will use thematic analysis to analyse qualitative data. ETHICS AND DISSEMINATION: Regional Committee for Medical and Health Research Ethics, Norway; Nepal Health Research Council, Nepal and Institutional Review Committee, Kathmandu University School of Medical Sciences have approved the study. The DiPEP package can be implemented in other communities of Nepal if it is effective in preventing diabetes. TRIAL REGISTRATION NUMBER: NCT04074148, 2019/783.

Iron Deficiency and Anemia 10 Years After Roux-en-Y Gastric Bypass for Severe Obesity.

Iron deficiency with or without anemia is a well-known long-term complication after Roux-en-Y, gastric bypass (RYGB) as the procedure alters the gastrointestinal absorption of iron. Iron is essential for hemoglobin synthesis and a number of cellular processes in muscles, neurons, and other organs. Ferritin is the best marker of iron status, and in a patient without inflammation, iron deficiency occurs when ferritin levels are below 15 µg/L, while iron insufficiency occurs when ferritin levels are below 50 µg/L. Lifelong regular blood tests are recommended after RYGB, but the clinical relevance of iron deficiency and iron insufficiency might be misjudged as long as the hemoglobin levels are normal. The aim of this study was to explore the frequency of iron deficiency and iron deficiency anemia one decade or more after RYGB, the use of per oral iron supplements, and the frequency of intravenous iron treatment. Nine hundred and thirty patients who underwent RYGB for severe obesity at three public hospitals in Norway in the period 2003-2009 were invited to a follow-up visit 10-15 years later. Results from blood tests and survey data on the use of oral iron supplements and intravenous iron treatment were analyzed. Ferritin and hemoglobin levels more than 10 years after RYGB were available on 530 patients [423 (79.8%) women]. Median (IQR) ferritin was 33 (16-63) µg/L, and mean (SD) hemoglobin was 13.4 (1.3) g/dl. Iron deficiency (ferritin ≤ 15 µg/L) was seen in 125 (23.6%) patients; in addition, iron insufficiency (ferritin 16-50 µg/L) occurred in 233 (44%) patients. Mean (SD) hemoglobin levels were 12.5 (1.4) g/dl in patients with iron deficiency, 13.5 (1.2) g/dl in patients with iron insufficiency, 13.8 (1.3) g/dl in the 111 (21%) patients with ferritin 51-100 µg/L, and 13.8 (1.2) g/dl in the 55 (10%) patients with ferritin >100 µg/L. Two hundred and seventy-five (56%) patients reported taking oral iron supplements, and 138 (27.5%) had received intravenous iron treatment after the RYGB procedure. Iron deficiency or iron insufficiency occurred in two-thirds of the patients 10 years after RYGB, although more than half of them reported taking oral iron supplements.

Intravenous Iron Treatment in the Prevention of Iron Deficiency and Anaemia After Roux-en-Y Gastric Bypass.

BACKGROUND: Iron absorption is disturbed after Roux-en-Y gastric bypass (RYGB) and iron deficiency with or without anaemia affects almost half of all patients. Intravenous iron is an option when per oral iron is insufficient or not tolerated. This study explores whether routinely offering intravenous iron treatment when iron stores are empty can prevent anaemia and iron deficiency after RYGB. METHODS: This is a study of prospectively registered data on clinical information, haematological tests and intravenous iron treatment from 644 RYGB patients who underwent surgery between 2004 and 2013, postoperatively followed more than 5 years. Intravenous iron treatment was offered to patients with ferritin ≤ 15 µg/L. RESULTS: Clinical information was available for all patients at baseline and for 553/644 patients at 5 years; laboratory results were available for 540/644 patients at baseline and 411/644 patients after 5 years. The mean age was 39.8 (± 9.7) years. Overall, 187/483 (38.7%) women and 9/161 (5.6%) men were given intravenous iron treatment in the observation period. From baseline to 5 years, mean haemoglobin decreased by 0.3 g/dL in both men and women. Anaemia occurred in 18/311 (5.8%) women and 9/100 (9%) men at 5 years. Depleted iron stores (ferritin ≤ 15 µg/L) were seen among 44/323(13.6%) women and 3/102 (2.9%) men, and low iron stores (ferritin 16-50 µg/L) occurred in 144/326 (44.6%) women and 38/102 (37.3%) men 5 years after RYGB. CONCLUSION: By routinely offering intravenous iron treatment to patients with depleted iron stores after RYGB, haemoglobin levels were preserved. Half of the patients experienced low or depleted iron stores at 5 years.