Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism

Study Overview
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Brief Summary
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Objective: The purpose of this study is to determine the etiology of the weight increase in Depot-medroxyprogesterone Acetate (DMPA) users. Method: 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.

Official Title
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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

Conditions
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Insulin Resistance, Cardiovascular Disease, Bone Loss, Eating Disorders, Thrombosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-40 years new users of DMPA BMI<30kg/m² Exclusion Criteria: diabetes mellitus and 2 present or fasting glucose> 100mg/dl and / or blood glucose> 140mg/dl after ingestion of 75mg of oral glucose first-degree relatives with diabetes mellitus period of lactation hypertension, with or without treatment hyper and hypothyroidism chronic renal failure transplant of any organ women using drugs that may be related to weight gain and / or development of insulin resistance and chronic use of corticosteroids, antipsychotics, statins, and thiazide, hirsutism and/or hyperandrogenism polycystic Ovary Syndrome (PCOS) women with acanthosis nigricans women who have used depoprovera at some point in their reproductive lives, women who have performed bariatric surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance | insulin resistance diagnosed by hyperinsulinemic-euglycemic clamp at 0 and 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain | other arm of the study | 12 months | 
| eating disorder | other arm of the study | 12 months | 
| loss of bone mass | other arm of the study | 12 months | 
| changes in clotting factors | other arm of the study | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DMPA, insulin resistance, cardiovascular disease, BMI, weight gain, thrombosis