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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Colorado, Denver.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01719029
First received: October 29, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Gestational Diabetes Mellitus
Other: Low-Carbohydrate/Higher Fat Diet
Other: High Carbohydrate/Low fat diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Macronutrient Diet Composition on Maternal and Infant Metabolic Outcomes in Gestational Diabetes

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Glucose area-under-the-curve [ Time Frame: During 3 days of each diet treatment ] [ Designated as safety issue: No ]
    The average glucose area-under-the-curve over 3 days, calculated using 24-hour continuous glucose monitoring


Secondary Outcome Measures:
  • Infant Adiposity [ Time Frame: 2 weeks after birth ] [ Designated as safety issue: No ]
    Infant adiposity measured using Pea Pod


Estimated Enrollment: 44
Study Start Date: August 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional Diet
Low carbohydrate/higher fat diet: 40% carbohydrate, 45% fat, 15% protein
Other: High Carbohydrate/Low fat diet
Experimental: Complex Carbohydrate Diet
High complex carbohydrate/lower fat diet: 60% complex carbohydrate, 25% fat, 15% protein
Other: Low-Carbohydrate/Higher Fat Diet

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719029

Contacts
Contact: Linda A Barbour, MD, MSPH 303-724-3954 lynn.barbour@ucdenver.edu
Contact: Teri L. Hernandez, PhD, RN 303-724-3943 teri.hernandez@ucdenver.edu

Locations
United States, Colorado
University of Colorado, Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Teri L. Hernandez, PhD, RN    303-724-3943    teri.hernandez@ucdenver.edu   
Principal Investigator: Linda A. Barbour, MD, MSPH         
Sub-Investigator: Teri L. Hernandez, PhD, RN         
Sub-Investigator: Jacob E Friedman, PhD         
Sub-Investigator: Rachael E Van Pelt, PhD         
Sub-Investigator: Melanie S. Reece, PhD         
Sub-Investigator: Molly A Anderson, MS, RD         
Sub-Investigator: William T Donahoo, MD         
Sub-Investigator: Linda J Daniels, RD, CLSC         
Sponsors and Collaborators
University of Colorado, Denver
Kaiser Permanente
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01719029     History of Changes
Other Study ID Numbers: 07-0283
Study First Received: October 29, 2012
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
continuous glucose monitoring
gestational diabetes
diet therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on August 19, 2014