Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-02-28

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.

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Detailed Description

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Conditions

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Insulin Resistance Cardiovascular Disease Bone Loss Eating Disorders Thrombosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes