NCT01719029

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

7.5 years

First QC Date

October 29, 2012

Last Update Submit

June 8, 2015

Conditions

Gestational Diabetes Mellitus

Keywords

continuous glucose monitoringgestational diabetesdiet therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Infant Adiposity

    2 weeks after birth

Study Arms (2)

Conventional Diet

EXPERIMENTAL

Low carbohydrate/higher fat diet: 40% carbohydrate, 45% fat, 15% protein

Other: High Carbohydrate/Low fat diet

Complex Carbohydrate Diet

EXPERIMENTAL

High complex carbohydrate/lower fat diet: 60% complex carbohydrate, 25% fat, 15% protein

Other: Low-Carbohydrate/Higher Fat Diet

Interventions

Low-Carbohydrate/Higher Fat DietOTHER
Complex Carbohydrate Diet
High Carbohydrate/Low fat dietOTHER
Conventional Diet

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • hr \>/= 180 mg/dL
  • hr \>/= 155 mg/dL
  • hr \>/=140 mg/dL

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, Reece MS, Reynolds RM, de la Houssaye BA, Heerwagen M, Donahoo WT, Daniels LJ, Chartier-Logan C, Janssen RC, Friedman JE, Barbour LA. Women With Gestational Diabetes Mellitus Randomized to a Higher-Complex Carbohydrate/Low-Fat Diet Manifest Lower Adipose Tissue Insulin Resistance, Inflammation, Glucose, and Free Fatty Acids: A Pilot Study. Diabetes Care. 2016 Jan;39(1):39-42. doi: 10.2337/dc15-0515. Epub 2015 Jul 29.

    PMID: 26223240DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 1, 2012

Study Start

August 1, 2007

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

US(1)