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The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese women after having a baby. The purpose of the study is to determine if a low carbohydrate diet is associated with improvement in insulin sensitivity in postpartum women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | Subjects will receive standard counseling on obesity as part of routine postpartum care. | |
| Low carbohydrate diet education | Active Comparator | Subjects will receive educational materials regarding a low carbohydrate diet in addition to the standard counseling on obesity as part of routine postpartum care. |
|
| Low carbohydrate diet education with behavioral component | Active Comparator | Subjects will receive in person instruction regarding a low carbohydrate diet as part of a 12 week course, in addition to receiving educational materials regarding a low carbohydrate diet and the standard counseling on obesity as part of routine postpartum care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low carbohydrate diet education | Behavioral | A 200 page informational document that connects with an online application will be provided to subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity. | Homeostatic model assessment for measurement of insulin sensitivity will be computed with fasting insulin and glucose levels (fasting for at least 8 hours) with the following calculation: (glucose x insulin/22.5). This calculation is measured in molar units (mmol/L). | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity. | Homeostatic model assessment for measurement of insulin sensitivity will be computed with fasting insulin and glucose levels (fasting for at least 8 hours) with the following calculation: (glucose x insulin/22.5). This calculation is measured in molar units (mmol/L). | Baseline, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
This study is limited subjects that are postpartum; therefore, can only include female participants.
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| Name | Affiliation | Role |
|---|---|---|
| Sara O Jacobs, MD | University of Texas | Principal Investigator |
| Antonio Saad, MD | University of Texas | Principal Investigator |
| Ashley Salazar, WHNP | University of Texas | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22889687 | Background | Morkrid K, Jenum AK, Sletner L, Vardal MH, Waage CW, Nakstad B, Vangen S, Birkeland KI. Failure to increase insulin secretory capacity during pregnancy-induced insulin resistance is associated with ethnicity and gestational diabetes. Eur J Endocrinol. 2012 Oct;167(4):579-88. doi: 10.1530/EJE-12-0452. Epub 2012 Aug 13. | |
| 12151145 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2019 |
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| Low carbohydrate diet education with behavioral component | Behavioral | A 12 week course taught be a certified instructor will teach subjects about a low carbohydrate document. Subjects will also be given a 200 page informational document that connects with an online application. |
|
| Change in weight measured in pounds. | The subject will be weighed at baseline and at 3 months.The weight will be calculated in pounds. | Baseline, 3 months |
| Change in weight measured in pounds. | The subject will be weighed at baseline and at 6 months. The weight will be calculated in pounds. | Baseline, 6 months |
| Development of diabetes postpartum as measured by 2 hour glucose tolerance test. | As part of routine postpartum care, women at risk for diabetes have a glucose tolerance test performed within 3 months postpartum. | 3 months |
| Change in blood pressure as measured by blood pressure cuff in mmHg. | The subject will have blood pressure checked at baseline and at 3 months. Blood pressure will be calculated in mmHg. | Baseline, 3 months |
| Change in blood pressure as measured by blood pressure cuff in mmHg. | The subject will have blood pressure checked at baseline and at 6 months. Blood pressure will be calculated in mmHg. | Baseline, 6 months |
| Rooney BL, Schauberger CW. Excess pregnancy weight gain and long-term obesity: one decade later. Obstet Gynecol. 2002 Aug;100(2):245-52. doi: 10.1016/s0029-7844(02)02125-7. |
| 12761365 | Background | Foster GD, Wyatt HR, Hill JO, McGuckin BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman JS, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med. 2003 May 22;348(21):2082-90. doi: 10.1056/NEJMoa022207. |
| Aug 2, 2019 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D000078064 | Gestational Weight Gain |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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