Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism

Completed

• Conditions: Bone Loss; Cardiovascular Disease; Eating Disorders; Thrombosis; Insulin Resistance

• Registration Number: NCT01527526
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-07
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
insulin resistance	12 months	insulin resistance diagnosed by hyperinsulinemic-euglycemic clamp at 0 and 12 months

Secondary Outcome Measures

Name	Time	Method
loss of bone mass	12 months	other arm of the study
changes in clotting factors	12 months	other arm of the study
eating disorder	12 months	other arm of the study
weight gain	12 months	other arm of the study

Trial Locations

Locations (1)

University of Campinas; 🇧🇷 Campinas, São Paulo, Brazil