Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism
The purpose of this study is to determine the etiology of the weight increase in Depot-medroxyprogesterone Acetate (DMPA) users.
Prospective study with 100 women, aged 18-40 years old and BMI < 30kg/m², paired with users of a non hormonal method follow for two years. Will be included only women who never used DMPA. There will be evaluated habit, blood pressure, anthropometric measure, distribution of corporal fat, lipids profile and glycemia parameters every six months. Thirty women and their control group will performed a euglycemic-hyperinsulinemic clamp to evaluate the resistance of insulin, adiponectin,neuropeptide Y, apolipoprotein A/B and arterial evaluation with ultrasound, intimal and media measure. Anova analysis for repeated samples. The metabolic alterations should elucidate the etiology, and the beginning of the sub clinical cardiovascular disease should be shown/discarded with the arterial evaluation.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Prospective Study for Evaluation of the Insulin Resistance, Lipid Metabolism and Sub Clinical Cardiovascular Disease in Women Who Initiate the Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method With in Follow-up for Two Years|
- insulin resistance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]insulin resistance diagnosed by hyperinsulinemic-euglycemic clamp at 0 and 12 months
- weight gain [ Time Frame: 12 months ] [ Designated as safety issue: No ]other arm of the study
- eating disorder [ Time Frame: 12 months ] [ Designated as safety issue: No ]other arm of the study
- loss of bone mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]other arm of the study
- changes in clotting factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]other arm of the study
Biospecimen Retention: Samples Without DNA
Serum samples for determination of lipid profile, insulin, glucose, coagulation factors, neuropeptide Y and factors related to bone mineral density.
|Study Start Date:||February 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527526
|University of Campinas|
|Campinas, São Paulo, Brazil, 13083-888|
|Principal Investigator:||Luis Bahamondes, M.D.||University of Campinas, Brazil|