Clinical trial NCT04045353: A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth
Official title: A Randomized Trial of a Low Carbohydrate Diet Versus the Current Recommended Dietary Guidelines to Improve Health Outcomes in Obese Postpartum Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Postpartum Weight Retention
Insulin Sensitivity
Keywords: Low carbohydrate diet
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.
timeFrame: Baseline, 6 months
measure: Change in weight measured in pounds.
timeFrame: Baseline, 3 months
measure: Change in weight measured in pounds.
timeFrame: Baseline, 6 months
measure: Development of diabetes postpartum as measured by 2 hour glucose tolerance test.
timeFrame: 3 months
measure: Change in blood pressure as measured by blood pressure cuff in mmHg.
timeFrame: Baseline, 3 months
measure: Change in blood pressure as measured by blood pressure cuff in mmHg.
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Sara O Jacobs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Antonio Saad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Ashley Salazar, WHNP
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.