Diabetes, GestationalPhase 4NCT01280409
Metformin Postpartum for GDM RCT for Reduced Weight Retention
A Phase 4 study testing Metformin in people with Diabetes, Gestational, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Aug 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Hermann Hospital, Texas Medical Center
Houston, Texas, 77030
University of Texas Health Science Center at Houston, Professional Building
Houston, Texas, 77030
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diabetes, Gestational
- Being tested
- Metformin, Placebo
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
PlaceboDrug
Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Compounded placebo Receives: Drug: Placebo |
| Metformin | Experimental | Compounded metformin as the intervention Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
The weight change in kilograms defined as:
weight change = Weight(pp) - Weight(6wk)
Measured: within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)
Secondary outcomes (12)
Number of Participants Who Achieved Pre-pregnancy Weight
Measured: At 6 weeks postpartum
Number of Participants Who Achieved Their Ideal Body Weight
Measured: At 6 weeks postpartum
Hemoglobin a1c
We will calculate the change in hemoglobin a1c.
Measured: At 6 weeks postpartum
HDL, LDL, Triglyceride
We will calculate the change in LDL, HDL, and triglyceride levels.
Measured: At 6 weeks postpartum
Self-reported Compliance With Medications
Measured: 3 weeks postpartum
Self-reported Compliance With Medications
Measured: 6 weeks postpartum
Difficulty With Diet as Assessed by a 5-point Likert Scale
Measured: At 6 weeks postpartum
Difficulty With Exercise as Assessed by a 5-point Likert Scale
Measured: At 6 weeks postpartum
Difficulty With Medication as Assessed by a 5-point Likert Scale
Measured: At 6 weeks postpartum
Satisfaction With Diet as Assessed by a 5-point Likert Scale
Measured: At 6 weeks postpartum
Satisfaction With Exercise as Assessed by a 5-point Likert Scale
Measured: At 6 weeks postpartum
Satisfaction With Medication as Assessed by a 5-point Likert Scale
Measured: At 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gilstrap, Larry C, M.D.
- Responsible party
- Principal investigator, Jerrie Refuerzo, The University of Texas Health Science Center, Houston
- Investigators
- Jerrie S Refuerzo, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280409
- Sponsor's protocol ID
- HSC-MS-10-0426
- Status last verified
- Nov 2018
- First submitted
- 19 Jan 2011
- Last updated
- 28 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01280409
- Acronym / sponsor ID
- HSC-MS-10-0426
- Conditions
- Diabetes, Gestational
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Gilstrap, Larry C, M.D.
- Study start
- Jan 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Posted 28 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboCompounded placebo |
| Metformin | Experimental | Drug: MetforminCompounded metformin as the intervention |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminSubjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks | Drug | Metformin |
| PlaceboSubjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks. | Drug | Placebo |
Primary outcome
Weight Change
Time frame: 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)
12 secondary outcomes
Number of Participants Who Achieved Pre-pregnancy Weight
Time frame: At 6 weeks postpartum
Number of Participants Who Achieved Their Ideal Body Weight
Time frame: At 6 weeks postpartum
Hemoglobin a1c
Time frame: At 6 weeks postpartum
HDL, LDL, Triglyceride
Time frame: At 6 weeks postpartum
Self-reported Compliance With Medications
Time frame: 3 weeks postpartum
Self-reported Compliance With Medications
Time frame: 6 weeks postpartum
Difficulty With Diet as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum
Difficulty With Exercise as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum
Difficulty With Medication as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum
Satisfaction With Diet as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum
Satisfaction With Exercise as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum
Satisfaction With Medication as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerrie S Refuerzo, MD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Diabetes, Gestational, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change (time frame: within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.