Trial of Diet in Gestational Diabetes Mellitus: Metabolic Consequences to Mother and Offspring

NCT02244814 | Completed

• 1 other identifier: 14-1358
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The rapidly rising risk of gestational diabetes pregnant women demands that an effective diet strategy be developed due to the high risk of fetal overgrowth, which places the newborn at increased risk for childhood obesity and metabolic syndrome. The aims of this randomized clinical trial are to compare the effects of an 8-wk isocaloric higher complex carbohydrate/lower fat diet vs. a conventional lower carbohydrate (higher fat) diet on glycemic and lipid profiles, maternal insulin resistance, placenta nutrient transporters, the maternal microbiome, neonatal intrahepatic fat, and neonatal total adiposity (primary outcome). The investigators will then follow the infants for 1-yr and measure maternal breast milk and infant microbiome composition to observe if they impact net fat mass gain differently in infants exposed to one diet vs. the other. Identifying a diet for gestational diabetes mellitus women that can effectively alter maternal/fetal metabolism is critical to reducing short- and long-term metabolic risk in this growing cohort of mothers and infants and has the potential to be applicable to overweight/obese pregnant women.

Conditions

Gestational Diabetes Mellitus

Keywords

glucose; insulin resistance; dietary carbohydrate; dietary fat; adiposity; Air displacement plethysmography; Dual X-ray Absorptiometry; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Neonatal adiposity

  Air-displacement plethysmography

  5-7 days after birth

Secondary Outcomes (2)

• Maternal Insulin Resistance

  36 wks gestation

• Placental fatty acid transporter protein-2 expression

  Delivery

Other Outcomes (3)

• Oral glucose tolerance test

  Baseline, 36 wks

• Adipose Tissue Lipolysis

  Baseline, 36 wks

• Infant Adiposity

  Birth-12 mos

Study Arms (2)

Choosing Healthy Options in Carbohydrate Energy

EXPERIMENTAL

60% carbohydrate/25% fat/15% protein diet

Behavioral: Low Carbohydrate/Conventional; Behavioral: Choosing Healthy Options in Carbohydrate Energy

Low Carbohydrate/Conventional

ACTIVE COMPARATOR

40% carbohydrate/45% fat/15% protein

Behavioral: Low Carbohydrate/Conventional; Behavioral: Choosing Healthy Options in Carbohydrate Energy

Interventions

Low Carbohydrate/Conventional BEHAVIORAL

Lower-carbohydrate/conventional diet (usual care)

Choosing Healthy Options in Carbohydrate Energy; Low Carbohydrate/Conventional

Choosing Healthy Options in Carbohydrate Energy BEHAVIORAL

Choosing Healthy Options in Carbohydrate Energy

Choosing Healthy Options in Carbohydrate Energy; Low Carbohydrate/Conventional

Eligibility Criteria

• Age: Up to 36 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women will be between the ages of 20-36 yrs
• BMI of 26-39 kg/m2 at the time of diagnosis
• singleton pregnancy
• no oral hypoglycemic therapy before entering the study
• diagnosed with Gestational diabetes according to the criteria established by the American College of Obstetricians and Gynecologists, specifically, they will have 2 abnormal values on a 100-g 3 hr glucose tolerance test 205, 206: Fasting\>95 mg/dL but \<105 mg/dL; 1hr\> 180 mg/dL; 2 hr\>155 mg/dL; 3 hr\>140 mg/dL.

You may not qualify if:

• extreme hypertriglyceridemia
• overt diabetes
• suspected preexisting diabetes (A1C≥6.5%, Fasting glucose\>125 mg/dL, or random glucose \>200/mg/dL)
• women highly likely to fail diet by any of the following criteria will be excluded:1) Fasting glucose \>105 mg/dL, due to the higher likelihood of failing diet and requiring medical treatment 139; 2) Fasting triglyceride \> 400 mg/dL.
• non-English speaking
• Smokers (leading cause of low birth weight)
• Risk factors for placental insufficiency (hypertension, renal disease, thrombophilias, rheumatologic disease, preeclampsia, steroid use, history of pancreatitis, infectious disease, or intrauterine growth restriction)
• History of pancreatitis
• History of pre-term labor
• Taking beta blockers/glucocorticoids

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Colorado/Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Hernandez TL, Van Pelt RE, Anderson MA, Daniels LJ, West NA, Donahoo WT, Friedman JE, Barbour LA. A higher-complex carbohydrate diet in gestational diabetes mellitus achieves glucose targets and lowers postprandial lipids: a randomized crossover study. Diabetes Care. 2014;37(5):1254-62. doi: 10.2337/dc13-2411. Epub 2014 Mar 4.

  PMID: 24595632 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance; Obesity

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Teri L Hernandez, PhD, RN

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 19, 2014
• Study Start: July 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)