Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01527526

Acronym

DMPA

Enrollment

Registered

2012-02-07

Start date

2011-02-28

Completion date

2013-02-28

Last updated

2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

DMPA, insulin resistance, cardiovascular disease, BMI, weight gain, thrombosis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results