NCT01280409

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

November 28, 2018

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

3.2 years

First QC Date

January 19, 2011

Results QC Date

February 29, 2016

Last Update Submit

November 1, 2018

Conditions

Diabetes, Gestational

Outcome Measures

Primary Outcomes (1)

  • Weight Change

    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)

Secondary Outcomes (12)

  • Number of Participants Who Achieved Pre-pregnancy Weight

    At 6 weeks postpartum

  • Number of Participants Who Achieved Their Ideal Body Weight

    At 6 weeks postpartum

  • Hemoglobin a1c

    At 6 weeks postpartum

  • HDL, LDL, Triglyceride

    At 6 weeks postpartum

  • Self-reported Compliance With Medications

    3 weeks postpartum

  • +7 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Compounded placebo

Drug: Placebo

Metformin

EXPERIMENTAL

Compounded metformin as the intervention

Drug: Metformin

Interventions

MetforminDRUG

Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks

Metformin
PlaceboDRUG

Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.

Placebo

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Hermann Hospital, Texas Medical Center

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at Houston, Professional Building

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Metformin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Dr Jerrie Refuerzo
Organization
University of Texas Health Science Center at Houston
Jerrie.S.Refuerzo@uth.tmc.edu
713.500.7780

Study Officials

  • Jerrie S Refuerzo, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 20, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2014

Study Completion

August 1, 2014

Last Updated

November 28, 2018

Results First Posted

November 28, 2018

Record last verified: 2018-11

Locations

US(2)