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| Name | Class |
|---|---|
| Gilstrap, Larry C, M.D. | INDIV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Compounded placebo |
|
| Metformin | Experimental | Compounded metformin as the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerrie S Refuerzo, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital, Texas Medical Center | Houston | Texas | 77030 | United States | ||
| University of Texas Health Science Center at Houston, Professional Building |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks. |
| FG001 | Metformin | Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks. |
| BG001 | Metformin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Change | The weight change in kilograms defined as: weight change = Weight(pp) - Weight(6wk) | Posted | Median | Full Range | kg | within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit) |
|
3 weeks postpartum
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jerrie Refuerzo | University of Texas Health Science Center at Houston | 713.500.7780 | Jerrie.S.Refuerzo@uth.tmc.edu |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks. |
|
| Hemoglobin a1c |
We will calculate the change in hemoglobin a1c. |
| At 6 weeks postpartum |
| HDL, LDL, Triglyceride | We will calculate the change in LDL, HDL, and triglyceride levels. | At 6 weeks postpartum |
| Self-reported Compliance With Medications | 3 weeks postpartum |
| Self-reported Compliance With Medications | 6 weeks postpartum |
| Difficulty With Diet as Assessed by a 5-point Likert Scale | At 6 weeks postpartum |
| Difficulty With Exercise as Assessed by a 5-point Likert Scale | At 6 weeks postpartum |
| Difficulty With Medication as Assessed by a 5-point Likert Scale | At 6 weeks postpartum |
| Satisfaction With Diet as Assessed by a 5-point Likert Scale | At 6 weeks postpartum |
| Satisfaction With Exercise as Assessed by a 5-point Likert Scale | At 6 weeks postpartum |
| Satisfaction With Medication as Assessed by a 5-point Likert Scale | At 6 weeks postpartum |
| Houston |
| Texas |
| 77030 |
| United States |
Compounded metformin as the intervention
Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants Who Achieved Pre-pregnancy Weight | Posted | Count of Participants | Participants | At 6 weeks postpartum |
|
|
|
| Secondary | Number of Participants Who Achieved Their Ideal Body Weight | Posted | Count of Participants | Participants | At 6 weeks postpartum |
|
|
|
| Secondary | Hemoglobin a1c | We will calculate the change in hemoglobin a1c. | This data is not reported because blood samples were not analyzed for Hemoglobin a1c. | Posted | At 6 weeks postpartum |
|
|
| Secondary | HDL, LDL, Triglyceride | We will calculate the change in LDL, HDL, and triglyceride levels. | This data is not reported because blood samples were not analyzed for HDL, LDL, and triglyceride. | Posted | At 6 weeks postpartum |
|
|
| Secondary | Self-reported Compliance With Medications | 46 in the placebo group and 53 in the metformin group were available by phone at 3 weeks postpartum to indicate medication compliance. | Posted | Count of Participants | Participants | 3 weeks postpartum |
|
|
|
| Secondary | Self-reported Compliance With Medications | Posted | Count of Participants | Participants | 6 weeks postpartum |
|
|
|
| Secondary | Difficulty With Diet as Assessed by a 5-point Likert Scale | Posted | Count of Participants | Participants | At 6 weeks postpartum |
|
|
|
| Secondary | Difficulty With Exercise as Assessed by a 5-point Likert Scale | Posted | Count of Participants | Participants | At 6 weeks postpartum |
|
|
|
| Secondary | Difficulty With Medication as Assessed by a 5-point Likert Scale | Posted | Count of Participants | Participants | At 6 weeks postpartum |
|
|
|
| Secondary | Satisfaction With Diet as Assessed by a 5-point Likert Scale | Posted | Count of Participants | Participants | At 6 weeks postpartum |
|
|
|
| Secondary | Satisfaction With Exercise as Assessed by a 5-point Likert Scale | Posted | Count of Participants | Participants | At 6 weeks postpartum |
|
|
|
| Secondary | Satisfaction With Medication as Assessed by a 5-point Likert Scale | Posted | Count of Participants | Participants | At 6 weeks postpartum |
|
|
|
| 0 |
| 56 |
| 7 |
| 56 |
| EG001 | Metformin | Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks | 0 | 46 | 12 | 46 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Medication Intolerance | General disorders | Systematic Assessment |
|
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| greater than 50% |
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| 100% |
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| greater than 50% |
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| 100% |
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| Moderately |
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| Quite |
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| Extremely |
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| Moderately |
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| Quite |
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| Extremely |
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| Moderately |
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| Quite |
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| Extremely |
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| Moderately |
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| Quite |
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| Extremely |
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| Moderately |
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| Quite |
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| Extremely |
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| Moderately |
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| Quite |
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| Extremely |
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