Role of Macronutrient Diet Composition and Infant Metabolic Outcomes in Gestational Diabetes

Gestational Diabetes Mellitus Clinical Trial

Official title:

Role of Macronutrient Diet Composition on Maternal and Infant Metabolic Outcomes in Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719029
• Other study ID #: 07-0283
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: June 8, 2015
• Start date: August 2007
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A better understanding of the optimal diet for women with gestational diabetes is fundamental to the management of this rapidly growing problem in pregnancy. Careful comparison studies of the current low- carbohydrate, higher-fat diet versus a diet higher in complex carbohydrate but lower in fat is critical in order to determine which diet results in a more favorable maternal 24-hour glucose, lipid, and inflammatory profile, all of which directly effect optimal fetal growth and may influence the future health of the offspring.

Description:

Despite the doubling in the prevalence of gestational diabetes mellitus (GDM) over the last 10 years, dietary management guidelines remain ambiguous due to the paucity of randomized controlled trials. New diagnostic criteria recently developed for the diagnosis of GDM are expected to increase the prevalence to 10-15% of all pregnant women. There is growing recognition that GDM has long-term implications on maternal risk for diabetes and that the intrauterine GDM environment is an independent risk factor for childhood obesity and impaired glucose tolerance. Yet, how diet can be used to modify fetal fuel and attenuate this risk remains unknown in humans. Fundamental to the management of GDM is dietary intervention, yet the historic practice of advising a low-carbohydrate (CHO), higher-fat diet has not been sufficiently tested. Both animal and non-human primate data support a fetal programming influence that maternal high-fat diets may promote insulin resistance, glucose intolerance, and hepatic steatosis in the offspring. Recent human data suggest that high maternal triglycerides (TG) and free fatty acids (FFA), variables sensitive to dietary manipulation, are independent risk factors for fetal macrosomia and adiposity. As a result, consensus groups have abandoned any specific diet recommendations for women with GDM. Despite the pivotal role of diet therapy in the treatment of GDM, no randomized trials have directly compared glycemic and lipoprotein profiles of the conventional higher-fat diet with any other diet. To address this critical need, the aims of this randomized cross-over trial are to study the effects of a high complex carbohydrate/low-fat diet (HC/LF; 60% CHO, 25% fat, 15% protein) compared to the usual care, low-CHO/higher fat diet (LC/HF; 40% CHO, 45% fat, and 15% protein) in GDM women on: 1) 72-hour glycemic profiles using a continuous glucose monitoring system within subjects; 2) postprandial lipemia by measuring serial plasma TG and FFA over a 5-hour, post-breakfast meal period within subjects; and 3) maternal lipoproteins, inflammatory profiles, and in-vitro adipose tissue lipolysis after 6-8 weeks of diet therapy between subjects. We will also measure neonatal adiposity by air displacement plethysmography and newborn markers of lipid peroxidation, inflammation, and dietary fat intake in the babies born to mothers with GDM. This pilot study will directly test which GDM diet is most effective in limiting maternal hyperglycemia and hyperlipidemia in a randomized controlled fashion, potentially optimizing fetal substrate availability and fetal growth. Our goal is to determine which diet intervention might favorably impact a cycle that could otherwise perpetuate future diabetes, obesity, and CVD in both mother and offspring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:Inclusion Criteria. Potential participants will be = 0-36 years old, which includes the offspring of the pregnant mothers with GDM. Pregnant women will be between the ages of 18-40 years and will have a BMI of 26 - 35 kg/m2 at the time of diagnosis, a singleton pregnancy, and will not be taking medication for their GDM on entrance to the study. Subjects will have been diagnosed with GDM according to the criteria established by the ADA and the ACOG (19;35;53), specifically, they will meet the following criteria:

• A 50-gram Glucola in which the one hour reading is >200 mg/dL and the FBG is >95 mg/dL

• Two abnormal values on a 100-gram 3 hour glucose tolerance test based on the Coustan and Carpenter criteria as adopted by the ADA and Fourth International Workshop on Gestational Diabetes (76;77):

• Fasting > or = to 95 mg/dL but <126 mg/dL

• 1 hr >/= 180 mg/dL

• 2 hr >/= 155 mg/dL

• 3 hr >/=140 mg/dL

Exclusion Criteria:Those women with overt diabetes and those suspected of having preexisting diabetes by any of the following criteria will be excluded, including:

• Fasting glucose >110 mg/dL, due to the high likelihood of rapidly failing diet and requiring medical treatment (35).

• Random glucose > 200 mg/dL

• Glycosylated hemoglobin A1C > 6.5

• Non-English speaking patient

• Fasting TG > 400 mg/dL

Women who smoke will be excluded since this is the leading cause of low birth weight. In addition, women with other risk factors for placental insufficiency, including hypertension requiring beta-blocker treatment, renal disease, thrombophilias, preeclampsia, steroid use, history of pancreatitis or infectious disease such as hepatitis, or intrauterine growth restriction will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Other:
• Low-Carbohydrate/Higher Fat Diet

• High Carbohydrate/Low fat diet

Locations

Country	Name	City	State
United States	University of Colorado, Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose area-under-the-curve	The average glucose area-under-the-curve over 3 days, calculated using 24-hour continuous glucose monitoring	During 3 days of each diet treatment	No
Secondary	Infant Adiposity	Infant adiposity measured using Pea Pod	2 weeks after birth	No