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Carbohydrate Restriction for Gestational Diabetes Mellitus

NCT00911404 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2016-08-23

No results posted yet for this study

Summary

There is evidence that controlling total amount of carbohydrates is a strategy for controlling glucose levels in diabetes mellitus. There is not major evidence that any given macronutrient percentage may be recommended to treat a woman with Gestational Diabetes Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy. Insulin treatment is more expensive and not as well accepted as MNT. The investigators have designed a randomized-controlled trial to assess whether a diet with 40% total calories from carbohydrates may reduce the need of insulin treatment in women with gestational diabetes, without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total calories from carbohydrates.

Conditions

  • Gestational Diabetes Mellitus (GDM)

Interventions

BEHAVIORAL

Low CHO

Diet with 40% total calories from carbohydrates. In the "Low-CHO" arm, 15% of calories from carbohydrates will be substituted by monounsaturated fat.

DIETARY_SUPPLEMENT

High CHO diet

Diet with 55% total calories from carbohydrates.

Sponsors & Collaborators

  • Hospital Arnau de Vilanova

    lead OTHER

Principal Investigators

  • Didac Mauricio, MD PhD · Hospital Universitari Arnau de Vilanova

  • Marta Hernández, MD · Hospital Universitari Arnau de Vilanova

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00911404 on ClinicalTrials.gov