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Metformin Postpartum for GDM RCT for Reduced Weight Retention

1. november 2018 opdateret af: Jerrie Refuerzo, The University of Texas Health Science Center, Houston

The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial

The purpose of this study is to determine whether the study drug metformin is helpful in reducing weight after pregnancy in women with gestational diabetes. This pilot study will provide information on how well women are able to take metformin postpartum, whether metformin increases weight loss, and whether there are any increased risks of side effects to you as a new mother.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

At 24-48 hours after delivery, women who are eligible for participation will be approached and consented to the study. Maternal weight will be measured and 20ml of maternal blood will be obtained to assess glucose control and lipid profile. Women will be counseled regarding diet, exercise and glucose control. Data including maternal demographics, clinical characteristics and neonatal outcomes will be collected. At 3 weeks postpartum, a research nurse will contact the subject via telephone call to inquire about adverse or side effects, ability to take the prescribed medication (metformin or placebo), and to answer questions about the study. At 6 weeks postpartum, maternal weight will be measured , blood will be obtained and side effects will be evaluated again. Finally, a satisfaction survey will be completed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

114

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Memorial Hermann Hospital, Texas Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas Health Science Center at Houston, Professional Building

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 49 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Postpartum women with a delivery greater than 34 weeks of pregnancy
  • Between the ages of 18 to 49 years
  • Women with a diagnosis of gestational diabetes mellitus (either treated with insulin, oral hypoglycemic agent or diet-controlled) after 24 weeks in most recent pregnancy based on a confirmatory 3 hour glucola test (based on either the Carpenter and Coustan's of the Diabetes Task Force criteria)

Exclusion Criteria:

  • women with pre-gestational diabetes mellitus (either Type I or Type II DM)
  • women unable to tolerate metformin based on patient history
  • women who will be discharged hom eon insulin or oral hypoglycemic agent in the immediate postpartum period
  • women with a BMI <25 kg/m²

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Compounded placebo
Medicin: Placebo
Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.
Eksperimentel: Metformin
Compounded metformin as the intervention
Medicin: Metformin
Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight Change
Tidsramme: within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)

The weight change in kilograms defined as:

weight change = Weight(pp) - Weight(6wk)
within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Achieved Pre-pregnancy Weight
Tidsramme: At 6 weeks postpartum
At 6 weeks postpartum
Number of Participants Who Achieved Their Ideal Body Weight
Tidsramme: At 6 weeks postpartum
At 6 weeks postpartum
Hemoglobin a1c
Tidsramme: At 6 weeks postpartum
We will calculate the change in hemoglobin a1c.
At 6 weeks postpartum
HDL, LDL, Triglyceride
Tidsramme: At 6 weeks postpartum
We will calculate the change in LDL, HDL, and triglyceride levels.
At 6 weeks postpartum
Self-reported Compliance With Medications
Tidsramme: 3 weeks postpartum
3 weeks postpartum
Self-reported Compliance With Medications
Tidsramme: 6 weeks postpartum
6 weeks postpartum
Difficulty With Diet as Assessed by a 5-point Likert Scale
Tidsramme: At 6 weeks postpartum
At 6 weeks postpartum
Difficulty With Exercise as Assessed by a 5-point Likert Scale
Tidsramme: At 6 weeks postpartum
At 6 weeks postpartum
Difficulty With Medication as Assessed by a 5-point Likert Scale
Tidsramme: At 6 weeks postpartum
At 6 weeks postpartum
Satisfaction With Diet as Assessed by a 5-point Likert Scale
Tidsramme: At 6 weeks postpartum
At 6 weeks postpartum
Satisfaction With Exercise as Assessed by a 5-point Likert Scale
Tidsramme: At 6 weeks postpartum
At 6 weeks postpartum
Satisfaction With Medication as Assessed by a 5-point Likert Scale
Tidsramme: At 6 weeks postpartum
At 6 weeks postpartum

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Health Science Center, Houston

Samarbejdspartnere

Gilstrap, Larry C, M.D.

Efterforskere

  • Ledende efterforsker: Jerrie S Refuerzo, MD, The University of Texas Health Science Center, Houston

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Faktiske)

1. marts 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

19. januar 2011

Først indsendt, der opfyldte QC-kriterier

19. januar 2011

Først opslået (Skøn)

20. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HSC-MS-10-0426

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes, svangerskabssyge

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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