no diabetic, obese subjects with BMI=40 kg.m-2 MedDRA version: 9.1 Level: LLT Classification code 10029883 Term: Obesity
Conditions
Interventions
Product Name: EXENATIDE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: EXENATIDE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (a) both sexes; (b) age between 30 and 60; (c) BMI ≥ 40 kg.m-2; (d) plasmatic glucose on fasting =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (a) diabetes type 2; (b) pregnancy, breast feeding and women in fertil age who don't use any contraceptive method , or who present positive test pregnancy; (c) psychiatric troubles; (d) troubles of alimentary behaviour (nervous anorexia or nervous bulimia ); (e) blindness, (f) serious clinic conditions(hepatic cirrhosis , renal insufficiency (creatinine > 2.0 mg/dl), malignant neoplasia , cardiac insufficiency, recent stroke, angina pectoris (g) treatment with pharmacological agents that influence carbohydrate homeostasis or antidepressant drugs (h) disorder of the gastrointestinal motility, (i) partecipation in other clinic study or in four weeks previous the recruitment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that exenatide influences, in obese subjects, hepatic glucose retention in physiologic post-prandial conditions;Secondary Objective: To value the effect of 3 months of treatment with exenatide vs no treatment(control group) on: 1. ß-cell function and glucose sensibility of ß-cell 2. insuline sensibility 3. hormones (insuline, glucagone, C-peptide, GIP, GLP-1, ghrelin) 4. lipidic profile 5. standard biochemical parameters 6. pro-inflammatory markers 7. weight;Primary end point(s): valutation of hepatic glucose retention | — |
Countries
Italy
Outcome results
None listed