Effect of intermittent very-low-calorie diet on glycemic control and cardiovascular risk factors in obese patients with type 2 diabetes mellitus
Phase 3
Recruiting
- Conditions
- Diabetes mellitus type 2ObesityDietary interventionintermittent very low calorie diettype 2 diabetes mellitusObesityCardiovascular risk factorsQuality of life
- Registration Number
- TCTR20160118001
- Lead Sponsor
- King Chulalongkorn Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
1. Personnel of King Chulalongkorn Memorial Hospital with type 2 diabetes
2. Age 20-60 years
3. Glycated hemoglobin level > 6.5%
4. Diabetes duration < 10 years
5. BMI > 23 kg/m2
Exclusion Criteria
1. Patients were treated with TZD, GLP-1 agonist or insulin treatment.
2. Serum creatinine > 1.5 mg/dL
3. Serum ALT > 2.5 folds above UNL
4. Serum C-peptide < 1 nmol/L
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diabetes remission 0, 2, 10, 20 week of study 75 gm OGTT
- Secondary Outcome Measures
Name Time Method Cardiovascular risk factors 0, 2, 10, 20 weeks of study Blood levels of inflammatory cytokines, body composition