Effects of weight reducing surgery and liraglutide on blood glucose in diabetes.

• Conditions: type 2 diabetes with morbid obesity; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-000397-19-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-08
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified