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NCT01280409 · ClinicalTrials.gov registry record · Phase 4
Metformin Postpartum for GDM RCT for Reduced Weight Retention
A Phase 4 study of Diabetes, Gestational, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 4
- Development phase
- 114
- Enrollment target
- 2
- Study locations
NCT01280409: Completed Phase 4 study of Diabetes, Gestational, sponsored by The University of Texas Health Science Center, Houston.
NCT01280409 is a Phase 4 study of Diabetes, Gestational that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 114 participants, below the 450-participant average among 5 other Diabetes, Gestational trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01280409, a Phase 4 study of Diabetes, Gestational, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 114 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The weight change in kilograms defined as: weight change = Weight(pp) - Weight(6wk)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin
Study Locations (2)
Texas
- Memorial Hermann Hospital, Texas Medical Center - Houston
- University of Texas Health Science Center at Houston, Professional Building - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2011-01 |
| Est. Completion | 2014-08 |
| Phase | Phase 4 |
What the finished NCT01280409 record still lists
NCT01280409 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 450-participant average among 5 other Diabetes, Gestational trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Diabetes, Gestational appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01280409 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01280409 about?
NCT01280409 is a clinical study titled "Metformin Postpartum for GDM RCT for Reduced Weight Retention". 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...
What is the current status of trial NCT01280409?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 114 participants. The study started on 2011-01. Estimated completion is 2014-08.
What conditions does trial NCT01280409 study?
This clinical trial studies the following conditions: Diabetes, Gestational.
What interventions are being tested in trial NCT01280409?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT01280409?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01280409 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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