Obesity with a diagnosis of impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) or type 2 Diabetes Mellitus (T2DM) for less than 12 months, according to the American Diabetes Association (ADA) Guidelines MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Victoza
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
Sponsors
"G. d'Annunzio" University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: subjects with BMI >30, with a diagnosis of impaired glucose tolerance (IGT) or T2DM for less than 12 months, according to the American Diabetes Association (ADA) Guidelines, under diet therapy associated with metformin. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: type 1 DM, BMI12 months, treatment with oral antidiabetic agents (except metformin) or insulin within the last three months, uncontrolled hypertension (systolic/diastolic blood pressure >160/90 mmHg), significant co-morbid diseases such as kidney disease with glomerular filtration rate below 60 ml or liver disease (AST or ALT twice above the upper normal range), pregnancy or lactation; any contraindication to liraglutide (previous pancreatitis, inflammatory bowel disease, heart failure Class NYHA III-IV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess, in obese subjects with IGT or T2DM, the separate effects of liraglutide or lifestyle counselling on SAT and VAT distribution, circulating adipokine concentration, insulin sensitivity and beta-cell performance, oxidative stress and platelet activation after a modest and comparable weight loss (7% of initial body weight) achieved with either intervention;Secondary Objective: 2. to assess, in each treatment arm, whether changes in SAT and VAT distribution after the completion of the randomized treatment may be associated with: - modification in the release of adipokines relevant to the development of downstream complications of obesity such as T2DM and CV disease; - changes in insulin sensitivity, as assessed by the Matsuda index, and in beta-cell performance; - changes in oxidative stress and platelet activation. 3. to assess whether the baseline distribution of VAT and adipokine profile may be associated with baseline insulin sensitivity and beta-cell function, and whether changes in VAT/SAT ratio may predict changes in circulating adipokine concentrations, and/or changes in insulin sensitivity and/or changes in beta cell function, with either intervention.;Primary end point(s): changes in subcutaneous and visceral fat distribution after each intervention;Timepoint(s) of evaluation of this end point: after achievement of the weight loss goal. We anticipate to achieve the goal to lose 7% of initial body weight within 8 months (range 6 to 9 months) since the start of the randomized treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): modification in the release of adipokines, in insulin sensitivity, in betacell performance, in oxidative stress and platelet activation after each intervention.;Timepoint(s) of evaluation of this end point: after achievement of the weight loss goal. We anticipate to achieve the goal to lose 7% of initial body weight within 8 months (range 6 to 9 months) since the start of the randomized treatment. | — |
Countries
Italy
Contacts
Public ContactDepartment of Medicine and Aging
"G. d'Annunzio" University
Outcome results
None listed