Gastrointestinal hormones and genes associated to type 2 diabetes remission in non-morbid obesity after bariatric surgery
Completed
- Conditions
- Type 2 diabetesNutritional, Metabolic, EndocrineNon-insulin-dependent diabetes mellitus
- Registration Number
- ISRCTN57114193
- Lead Sponsor
- Fundación Mutua Madrileña (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Men and women
2. Ages 35-60
3. Type 2 diabetes diagnosed 1-10 years prior to recruitment
4. Body mass index (BMI) 30-40 kg/m2
5. C-peptide level > 1 ng/dL
6. Signed written informed consent
Exclusion Criteria
1. HbA1c levels > 6.5% or > 10% at the time of recruitment
2. Creatinine levels > 1.5 mg/dL
3. Ongoing pregnancy, either at the time of recruitment or follow-up
4. Renal failure (ClCr < 50 mL/min)
5. Liver disease
6. Psychiatric disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission of type 2 diabetes after metabolic surgery, defined as two categories: complete remission (fasting glucose < 100 mg/dl, normal HbA1c values) and partial remission (fasting glucose 100-125 mg/dl, HbA1c < 6.5%), in both cases in the absence of active pharmacologic treatment, at each time of follow-up (T1 and T2)
- Secondary Outcome Measures
Name Time Method 1. Changes in gastrointestinal hormones (ghrelin, insulin, glucagon, GIP, GLP-1, PYY3-36, oxyntomodulin, adiponectin, leptin and GLP-2) using values of area under the curve (AUC), for each bariatric procedure and comparison with a matched control group<br>2. Analysis of polymorphisms involved in type 2 diabetes and incretin metabolism