Effects of the treatment with metformin and/or sitagliptin on ß- cell function and insulin resistance in women with prior gestational diabetes. - ND

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1. Women between 18 and 50; 2. caucasian race; 3. positive anamnesis for gestational diabet in the previous pregnancy, fulfilled for at least 1 year; 4. diagnosis of previous GDM defined according to Carpenter and Coustan criteria, i.e. FPG value = 126 mg/dl and/or two or more of the following condition after a 100-g oral glucose load in the oral glucose tolerance test (OGTT)0`? = 95 mg/dl, 60`? = 180 mg/dl, 120`? = 155 mg/dl, 180`? = 140 mg/dl;5. Use of an efficacious contraceptive method for at least 1 month and for all study duration; 6. written consent.
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

1. Previous diagnosis of DM type 1 and/or positivity of autoantibodies anti pancreatic insules (anti-GAD, anti-IA2); 2. diagnosis of DM in the 75-g OGTT, performed at entry, defined as a FPG value = 126 mg/dl and/or a PG value = 200 mg/dl 2 hours after the glucose load; 3. BMI< 18 kg/m2 or > 50 kg/m2; 4. chronic impaired renal function; 5. total hemoglobin rate < 12 g/dl 6. impaired liver function as shown by transaminase level = twice above the upper normal range; 7. breast-feeding women; 8. pregnant women, or women planning to become pregnant during the study, 9. history of hypersensitivity to metformin; 10. failure to use adequate contraception (women of current reproductive potential only); 11. mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study; 12. any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, heamatological or other major systemic disease or infective diseases making implementation of the protocol or interpretation of the study results difficult; 13. patient with underlying concomitant medication requiring a long-term use of drug potentially acting on glucose metabolism (e.g. corticosteroids, diuretics, or others); 14. hisory of drug or alcohol abuse within the last two years or current addiction to substances of abuse, 15. any disease or condition that in the opinion of investigator may interfere with the completion of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confront the effect of the treatment with sitagliptin and metformin in association or in monotherapy on the beta-cellular function and on insulinic sensitivity in women with previous gestational diabetes (pGDM).;Secondary Objective: ;Primary end point(s): To value the effects of the treatment with sitagliptin and/or metformin, will be used as principal variable the beta-cellular function (ISR =Insulin Secretion Rate)calculated according to model proposed by Mari.

Secondary Outcome Measures