Mechanism of action and metabolic effects of exenatide in obesity - ND

Conditions: no diabetic, obese subjects with BMI=40 kg.m-2
MedDRA version: 9.1Level: LLTClassification code 10029883Term: Obesity

Registration Number: EUCTR2008-001869-29-IT

Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(a) both sexes; (b) age between 30 and 60; (c) BMI ≥ 40 kg.m-2; (d) plasmatic glucose on fasting < 7 mmol/l (126mg/dl) and plasmatic glucose after 2 hours from bolus during OGTT < 11.1 mmo/l (200 mg/dl) without antidiabetic treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures