Abdominal Obesity, Insulin Resistance
Conditions
Keywords
Pre-diabetes, Clamp technique, PPARs, Insulin resistance
Brief summary
The purpose of this study is to demonstrate the efficacy on insulin sensitivity of GFT505 at 80mg/d in male patients with insulin resistance and abdominal obesity. Evaluation will be made using a glucose clamp technique.
Detailed description
The study period per patient is 26 weeks: a selection period will precede a 8-week treatment period, a 6-week wash out period, a second 8-week treatment period in the second arm of treatment and a 2- week follow-up period. Schedule: * Selection visit prior to treatment period (D-14 and D-1) * D0 : randomisation visit * Period T1: first period of treatment with GFT505 80mg or placebo for 8 weeks (D1 to D56) * Wash out period for 6 weeks (D57 to D98) * Period T2: second period of treatment with GFT505 80mg or placebo for 8 weeks (D99 to D154) * Follow up period for 2 weeks (D155 to D169)
Interventions
DRUGGFT505 80mg
hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast
DRUGPlacebo
hard gelatin capsules, oral administration, 4 capsules per day before breakfast
Sponsors
Genfit
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Waist circumference ≥94cm. * Body Mass Index ≤ 45kg/m2. * Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) \> 3.
Exclusion criteria
* Blood Pressure \> 160 / 95 mmHg. * Diabetes mellitus 1 or 2. * Historical of bariatric surgery. * Patient treated with a lipid-decreasing medication. * A fasting plasma triglycerides concentration \> 400mg/dL or a plasma Low Density Lipoprotein Cholesterol (LDL-c)concentration \> 220mg/dL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Infusion Rate (GIR) | 8 weeks | To evaluate in each patient the differences in Glucose Infusion Rate (GIR) measured at the end of 8 weeks treatment periods with GFT505 (80 mg/day per os) or placebo according to a cross-over design. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Hepatic Glucose Production (HGP) in each patient | 8 weeks | To evaluate in each patient the differences in Hepatic Glucose Production (HGP) measured at the end of 8 weeks treatment periods with GFT505 (80 mg/day per os) or placebo according to a cross-over design. |
| Changes in GIR (Glucose Infusion Rate) | 8 weeks | To compare the changes from baseline to endpoint in Glucose Infusion Rate (GIR). The baseline will be defined as the values of glucose clamp at V2. The same baseline will be used for the 2 periods. End-points will be defined as glucose clamp values at V4 for the first period and as glucose clamp values at V7 for the second period. |
| Changes in HGP (Hepatic Glucose Production) | 8 weeks | To compare the changes from baseline to endpoint in Hepatic Glucose Production (HGP). The baseline will be defined as the values of glucose clamp at V2. The same baseline will be used for the 2 periods. End-points will be defined as glucose clamp values at V4 for the first period and as glucose clamp values at V7 for the second period. |
Countries
France
Outcome results
None listed