Diabetes Clinical Trial
— DiabOUTOfficial title:
Extending Time Without Diabetes After Bariatric Surgery: a Randomized Controlled Trial Comparing the Metformin Addition or Not to Standard Care
This study is a randomized trial that evaluates the effect of metformin addition or not to standard care on the duration of diabetes remission after bariatric surgery.
Status | Recruiting |
Enrollment | 126 |
Est. completion date | November 2026 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Adults 18-70 years old - Having undergone gastric bypass or sleeve gastrectomy 12 to 36 +/-3 months before inclusion - "ex-T2D" treated with at least one anti-diabetic drug before bariatric surgery or HbA1c = 6.5 % before bariatric surgery - HbA1C < 6.5 % at inclusion with no anti-hyperglycemic medications for the last three months - Written consent Exclusion Criteria: - Known type 1 diabetes - Pregnancy and breastfeeding - Estimated glomerular filtration rate<44 ml/min (MDRD) - Known intolerance to metformin - Known contraindication to metformin: - Acute metabolic acidosis - Acute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent within the last 48 hours) - Acute or chronic disease which could lead to a tissue hypoxia (ex : severe cardiac insufficiency, severe respiratory insufficiency, myocardial infarction within the last 3 months, shock) - Hepatocellular insufficiency - Prothrombin ratio = 50% - SGOT or SGPT levels = 10 times the upper limits of the normal range - Alcohol use disorder - Medications and medical conditions likely to confound the assessment of diabetes: - glucocorticoids treatment - renal graft - Cushing's syndrome - acromegaly - fasting plasma triglyceride > 600 mg/dl despite treatment - Patient under legal protection |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens-Picardie - hôpital Nord | Amiens | |
France | AP-HP - hôpital Avicenne | Bobigny | |
France | CHU de Bordeaux - hôpital Haut-Lévêque | Bordeaux | |
France | AP-HP - hôpital Ambroise-Paré | Boulogne-Billancourt | |
France | AP-HP - hôpital Louis-Mourier | Colombes | |
France | Centre hospitalier intercommunal de Créteil | Créteil | |
France | CHU de Lille - hôpital Claude Huriez | Lille | |
France | AP-HM - hôpital de la Conception | Marseille | |
France | AP-HM - hôpital Nord | Marseille | |
France | AP-HP - hôpital Bichat-Claude Bernard | Paris | |
France | AP-HP - hôpital de la Pitié-Salpêtrière | Paris | |
France | AP-HP - hôpital européen Georges-Pompidou | Paris | |
France | Institut Mutualiste Montsouris | Paris | |
France | HCL - centre hospitalier Lyon-Sud | Pierre-Bénite | |
France | CH de Saint-Denis - hôpital Delafontaire | Saint-Denis | |
France | CHU de Toulouse - hôpital Larrey | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with partial or complete T2D remission criteria | Complete remission: HbA1c<5.7% and no anti-diabetic medications (except metformin in the experimental group).
Partial remission: defined as prediabetes level of glycaemia i.e. HbA1c<6.5% and no anti-diabetic medications (except metformin in the experimental group). |
3 years | |
Secondary | Proportion of patients with partial or complete T2D remission criteria | Complete remission: HbA1c<5.7% and no anti-diabetic medications (except metformin in the experimental group).
Partial remission: defined as prediabetes level of glycaemia i.e. HbA1c<6.5% and no anti-diabetic medications (except metformin in the experimental group). |
1 and 2 years | |
Secondary | Proportion of patients with strict complete T2D remission criteria | 3 years | ||
Secondary | Percentage of weight and BMI change | 1, 2 and 3 years | ||
Secondary | Fasting glycemia | Assessment of the level of cardio-metabolic parameters associated to T2D. Fasting glycemia and insulinemia will be combined to report HOMA-IR (homeostatic model assessment - insulin resistance). | 1, 2 and 3 years | |
Secondary | Fasting insulinemia | Assessment of the level of cardio-metabolic parameters associated to T2D. Fasting glycemia and insulinemia will be combined to report HOMA-IR (homeostatic model assessment - insulin resistance). | 1, 2 and 3 years | |
Secondary | Level of blood triglycerides | Assessment of the level of cardio-metabolic parameters associated to T2D. | 1, 2 and 3 years | |
Secondary | Level of blood HDL cholesterol | Assessment of the level of cardio-metabolic parameters associated to T2D. | 1, 2 and 3 years | |
Secondary | Blood pressure | Systolic and diastolic blood pressure. | 1, 2 and 3 years | |
Secondary | Level of blood albumin | Level of nutritional parameters associated with BS | 1, 2 and 3 years | |
Secondary | Level of blood hemoglobin | Level of nutritional parameters associated with BS | 1, 2 and 3 years | |
Secondary | Level of blood iron | Level of nutritional parameters associated with BS | 1, 2 and 3 years | |
Secondary | Level of serum ferritin | Level of nutritional parameters associated with BS | 1, 2 and 3 years | |
Secondary | Transferrin saturation percentage | Level of nutritional parameters associated with BS | 1, 2 and 3 years | |
Secondary | Level of blood calcium | Level of nutritional parameters associated with BS | 1, 2 and 3 years | |
Secondary | Level of blood vitamin D | Level of nutritional parameters associated with BS | 1, 2 and 3 years | |
Secondary | Level of blood vitamin B1 | Level of nutritional parameters associated with BS | 1, 2 and 3 years | |
Secondary | Level of blood vitamin B9 | Level of nutritional parameters associated with BS | 1, 2 and 3 years | |
Secondary | Level of blood vitamin B12 | Level of nutritional parameters associated with BS | 1, 2 and 3 years | |
Secondary | Proportion of adverse effects in the intervention group compared to standard care | 3 years | ||
Secondary | Number of pills taken per patient | Adherence level assessment in the intervention group. Compliant patients are defined as taking at least 80% of assigned study pills in the intervention group. | 1, 2 and 3 years | |
Secondary | Level of plasmatic metformin | Adherence level assessment in the intervention group. | 1, 2 and 3 years | |
Secondary | Proportion of retinopathy events | 3 years | ||
Secondary | Proportion of nephropathy events | 3 years | ||
Secondary | Proportion of macroangiopathy events | 3 years | ||
Secondary | Numbers and proportions of patients with quality of life changes | assessed by EuroQol 5 Dimensions (EQ5D) auto-questionnaire | 1, 2 and 3 years | |
Secondary | Clinical outcome at the end of the study | assessed by 5-year-Advanced-Diabetes Remission (5y-Ad-DiaRem) score | 3 years | |
Secondary | Changes in fecal microbiota | 1 and 3 years | ||
Secondary | Glycemia | 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal | ||
Secondary | Insulinemia | 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal | ||
Secondary | Level of glucagon | 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal | ||
Secondary | Level of GLP-1 | 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal | ||
Secondary | Level of GLP-2 | 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal | ||
Secondary | Level of GIP | 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal | ||
Secondary | Level of oxyntomodulin | 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal | ||
Secondary | Level of PYY | 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal | ||
Secondary | Level of ghrelin | 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal | ||
Secondary | Level of glicentin | 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05594446 -
Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
|
||
Completed |
NCT03975309 -
DHS MIND Metabolomics
|
||
Completed |
NCT01855399 -
Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes
|
N/A | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Recruiting |
NCT05007990 -
Caregiving Networks Across Disease Context and the Life Course
|
||
Active, not recruiting |
NCT04420936 -
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
|
N/A | |
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Completed |
NCT04903496 -
Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
|
||
Completed |
NCT01437592 -
Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT03390179 -
Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Recruiting |
NCT05294822 -
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
|
N/A | |
Completed |
NCT04427982 -
Dance and Diabetes/Prediabetes Self-Management
|
N/A | |
Completed |
NCT02356848 -
STEP UP to Avert Amputation in Diabetes
|
N/A | |
Completed |
NCT03292185 -
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
|
Phase 1 | |
Active, not recruiting |
NCT05477368 -
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
|
N/A | |
Completed |
NCT04496401 -
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
|
Phase 4 |