Clinical trial NCT01527526: Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Cardiovascular Disease
Bone Loss
Eating Disorders
Thrombosis
Keywords: DMPA
insulin resistance
cardiovascular disease
BMI
weight gain
thrombosis
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-02-07
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Will be included women new-users DMPA, looking for the clinic's family planning FCM-UNICAMP, from primary care centers in Campinas, São Paulo, 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.


Eligibility criteria: 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

Primary outcomes:
measure: insulin resistance
timeFrame: 12 months
Secondary outcomes:
measure: weight gain
timeFrame: 12 months
measure: eating disorder
timeFrame: 12 months
measure: loss of bone mass
timeFrame: 12 months
measure: changes in clotting factors
timeFrame: 12 months
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University of Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Luis Bahamondes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Modesto W, Bahamondes MV, Silva dos Santos P, Fernandes A, Dal'Ava N, Bahamondes L. Exploratory study of the effect of lifestyle counselling on bone mineral density and body composition in users of the contraceptive depot-medroxyprogesterone acetate. Eur J Contracept Reprod Health Care. 2014 Aug;19(4):244-9. doi: 10.3109/13625187.2014.924098. Epub 2014 Jun 13.