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NCT02179788 · ClinicalTrials.gov registry record · Phase 1
Metformin to Augment Low Milk Supply (MALMS) Study
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02179788 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 15 participants.
The verdict
NCT02179788, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Most new mothers in the United States will start off breastfeeding. For some mothers, despite following best practices, they are not able to meet their breastfeeding goals due to unexplained low milk supply. At the same time, nearly 1 in 4 new mothers are pre-diabetic (elevated blood sugar, but not yet diabetic). My progression of research suggests that the same metabolic factors causing pre-diabetes may also be causing low milk supply. Metformin is a widely prescribed drug to treat high blood sugar. This study is a preliminary, small scale randomized trial designed to test for a trend in the hypothesis that metformin is safe and potentially effective in treating low milk supply in insulin resistant and pre-diabetic mothers.
Interventions
- DRUG Placebo
- DRUG Metformin
- BEHAVIORAL Standard care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02179788
The ClinicalTrials.gov registry entry for NCT02179788 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02179788 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02179788 about?
NCT02179788 is a clinical study titled "Metformin to Augment Low Milk Supply (MALMS) Study". Most new mothers in the United States will start off breastfeeding. For some mothers, despite following best practices, they are not able to meet their breastfeeding goals due to unexplained low milk supply. At the same time, nearly 1 in 4 new mothers are pre-diabetic (elevated blood sugar, but not ...
What is the current status of trial NCT02179788?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-06. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02179788?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Standard care (BEHAVIORAL).
Who is sponsoring clinical trial NCT02179788?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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