Effect of a bean extract on glucose metabolism in obesity
Not Applicable
- Conditions
- Glycometabolic control in patients with severe obesityNutritional, Metabolic, EndocrineObesity
- Registration Number
- ISRCTN67373128
- Lead Sponsor
- Istituto Auxologico Italiano
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 208
Inclusion Criteria
1. Obesity (BMI =35 kg/m²) with or without comorbidities
2. 18 to 65 years of age
3. Dysglycemia, altered fasting glycemia or insulin resistance (HOMA index >2.5)
4. Possibility to be followed in the follow up at Auxologico Via Ariosto (Milan)
5. Negative swab for COVID-19 at enlistment
Exclusion Criteria
1. Type 1 and 2 diabetes in treatment
2. Previous operations of bariatric surgery
3. Psychiatric illness
4. Inflammatory bowel disease
5. Untreated thyroid
6. Past or present history of malignant neoplasia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Insulin resistance measured using the HOMA Index before and after P.V. extract or placebo treatment at baseline (T0), after 2 weeks (T1), 4 weeks (T2) and after 12 weeks (T6)<br> 2. Serum concentrations of glycated haemoglobin, glucose and insulin measured from blood samples taken before P.V. extract or placebo intake, baseline (T0), after 2 weeks (T1), 4 weeks (T2) and 12 weeks (T6) from the start of treatment<br>
- Secondary Outcome Measures
Name Time Method