A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth

Not Applicable

Terminated

• Conditions: Insulin Sensitivity; Postpartum Weight Retention; Obesity

• Registration Number: NCT04045353
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Study Start: 2019-12-20
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 11

Inclusion Criteria

• Delivery at University of Texas Medical Branch
• Body max index greater than or equal to 30 kilograms/meters squared at the final prenatal visit prior to delivery.
• Singleton gestation.
• Accessibility to the internet.
• Basic understanding and comprehension of the English language to be assessed by study personnel at the time of recruitment.

Exclusion Criteria

• Diabetes mellitus on medication.
• Serious medical condition, such as heart failure, kidney failure, or severe asthma, as determined by the principle investigator.
• Planned pregnancy during study period.
• Enrolled in another trial that may affect outcome.
• Subject unlikely to be followed up after delivery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.	Baseline, 3 months	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).

Secondary Outcome Measures

Name	Time	Method
Change in weight measured in pounds.	Baseline, 6 months	The subject will be weighed at baseline and at 6 months. The weight will be calculated in pounds.
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.	Baseline, 6 months	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).
Development of diabetes postpartum as measured by 2 hour glucose tolerance test.	3 months	As part of routine postpartum care, women at risk for diabetes have a glucose tolerance test performed within 3 months postpartum.
Change in blood pressure as measured by blood pressure cuff in mmHg.	Baseline, 6 months	The subject will have blood pressure checked at baseline and at 6 months. Blood pressure will be calculated in mmHg.

Trial Locations

Locations (1)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States