Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism

Cardiovascular Disease Clinical Trial

— DMPA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527526
• Other study ID #: 09/2011/PC
• Status: Completed
• Phase: N/A
• First received: November 16, 2011
• Last updated: June 3, 2015
• Start date: February 2011
• Est. completion date: February 2013

Study information

• Verified date: June 2015
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Loss
• Cardiovascular Disease
• Cardiovascular Diseases
• Eating Disorders
• Insulin Resistance
• Thrombosis

Locations

Country	Name	City	State
Brazil	University of Campinas	Campinas	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin resistance	insulin resistance diagnosed by hyperinsulinemic-euglycemic clamp at 0 and 12 months	12 months	Yes
Secondary	weight gain	other arm of the study	12 months	No
Secondary	eating disorder	other arm of the study	12 months	No
Secondary	loss of bone mass	other arm of the study	12 months	No
Secondary	changes in clotting factors	other arm of the study	12 months	No