type 2 diabetes with morbid obesity
Conditions
Interventions
Trade Name: liraglutide
Pharmaceutical Form: Solution for injection in pre-filled pen
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administration of the placeb
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - give written informed consent, - age = 18 and =65 years, - type 2 diabetes mellitus on diet/lifestyle intervention with or without metformin, - a body mass index = 35 kg/m2 (1991 NIH Guidelines for Bariatric Surgery), - for women of childbearing age, must have a negative pregnancy test at screening, and agree to use contraceptives for the duration of the study, - are able to understand and comply with the study process. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - a diagnosis of type 1 diabetes mellitus, LADA or MODY, - patients with severe gastrointestinal disease, including gastroparesis, - have a contraindication for bariatric surgery, - an endocrine form of obesity (e.g. Cushing syndrome), - breastfeeding - currently using or have used within three months before this trial: any drug for the treatment of obesity (patients must also agree to not use these medications for the duration of the study), - treatment with any investigational drug in the last 30 days, - symptomatic coronary heart disease, - impaired renal function (creatinin clearance < 60 ml/min/m2), - hepatic disease other than steotosis hepatis, - an active malignancy other than basal cell skin carcinoma, - previous treatment with GLP-1 receptor agonists (including liraglutide or exenatide) within the last 3 months, - use any other medication for the treatment diabetes than metformin (e.g. TZD, SU, DPP-IV inhibitors, insulin). If considered appropriate on the basis of glycemic regulation this medication can be stopped, thereby making patients eligible for the study. - have experienced hypersensitivity reaction or a worsening of glycemic control on GLP-1 receptor agonists (including liraglutide or exenatide), - a history of Major Depressive Disorder within the last 2 years, - a history of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder, - a PHQ-9 score of = 15, - any lifetime history of a suicidal attempt, - in the opinion of the investigator, patient is abusing alcohol and/or drugs, - screening calcitonin = 50 ng/L, - a family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC), - a personal history of non-familial medullary thyroid carcinoma, - a history of chronic pancreatitis or idiopathic acute pancreatitis. - Insufficient mental capacity in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the efficacy of 1.8 mg liraglutide compared to liraglutide-placebo in reducing glycemic variability and achieving glycemic control during 16 weeks treatment before surgery and 48 weeks (week 4 to 52) treatment after gastric bypass surgery for morbid obesity complicated by DM2.;Secondary Objective: To establish the efficacy of 1.8 mg liraglutide compared to liraglutide-placebo in inducing a change in body weight, cardiovascular risk profile and patient reported outcomes (quality of life, eating behaviour and dumping syndrome score). To establish a biobank containing blood (plasma), DNA, subcutaneous and visceral fat, as well as gastro-intestinal tissues with the intention to future research on the effects of liraglutide on adipose tissue and gastro-intestinal endocrine cells.;Primary end point(s): 1. Glycemic variability (glucose SD, Mean Amplitude of Glucose Excursions (MAGE), 24 hour glycemic variation) as measured by blinded CGM, 2. Glycemic control (SMBG and HbA1c, time spend in hyper- and hypoglycaemia, 1.5-anhydroglucitol), 3. Glucose peak and nadir after a Mixed Meal Tolerance Test (MMTT).;Timepoint(s) of evaluation of this end point: Change from baseline to day before operation and to 52 weeks post-operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline to day before operation and to 52 weeks post-operation in 1. percentage body weight, absolute body weight, and excess BMI. 2. Cardiovascular risk profile: waist circumference, systolic and diastolic blood pressure, hsCRP, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, urinary albumin-creatinin ratio, medication for hypertension and dyslipidemia. 3. Insulin, incretins and other gut hormones after an MMTT. 4. Quality of Life (SF-36), Dumping syndrome score, Eating behavior (Dutch Eating Behaviour Questionnaire).;Timepoint(s) of evaluation of this end point: Change from baseline to day before operation and to 52 weeks post-operation. | — |
Countries
Netherlands
Contacts
Public Contacta.p.van.beek@umcg.nl
University Medical Center Groningen
Outcome results
None listed