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Completed

NCT Number: NCT01527526

Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism

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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Key information

Conditions

Insulin Resistance Body Weight Body Weight Changes Bone Diseases Bone Diseases, Metabolic Bone Loss Cardiovascular Disease Cardiovascular Diseases Eating Disorders Embolism and Thrombosis Feeding and Eating Disorders Glucose Metabolism Disorders Hyperinsulinism Mental Disorders Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Thrombosis Vascular Diseases Weight Gain

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Campinas

Campinas, São Paulo, 13083-888, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. insulin resistance

    Time frame: 12 months

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

Secondary outcomes

  1. weight gain

    Time frame: 12 months

    other arm of the study

  2. eating disorder

    Time frame: 12 months

    other arm of the study

  3. loss of bone mass

    Time frame: 12 months

    other arm of the study

  4. changes in clotting factors

    Time frame: 12 months

    other arm of the study

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study 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

Acronym: DMPA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 7, 2012
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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