Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism (DMPA)
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
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.
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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São Paulo
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Campinas, São Paulo, Brasilien, 13083-888
- University of Campinas
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
insulin resistance
Tidsramme: 12 months
|
insulin resistance diagnosed by hyperinsulinemic-euglycemic clamp at 0 and 12 months
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12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
weight gain
Tidsramme: 12 months
|
other arm of the study
|
12 months
|
|
eating disorder
Tidsramme: 12 months
|
other arm of the study
|
12 months
|
|
loss of bone mass
Tidsramme: 12 months
|
other arm of the study
|
12 months
|
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changes in clotting factors
Tidsramme: 12 months
|
other arm of the study
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Luis Bahamondes, M.D., University of Campinas, Brazil
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 09/2011/PC
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