Skip to main content
OpenTrials
Completed

NCT Number: NCT00911404

Carbohydrate Restriction for Gestational Diabetes Mellitus

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational diabetes mellitus
  • Single pregnancy

Exclusion criteria

  • Multiple pregnancy
  • High risk pregnancy (any other concomitant illness, excluding hypertension and obesity)
  • Low ability to understand and follow a diet
  • Need to use insulin different from regular insulin

Treatment and study plan

Low CHO

Behavioral

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

High CHO diet

Dietary Supplement

Diet with 55% total calories from carbohydrates.

Primary outcomes

  1. Need of insulin treatment for GDM

    Time frame: Day of delivery

Secondary outcomes

  1. Time from GDM diagnosis free of insulin treatment

    Time frame: Day of delivery

  2. Maternal ketonemia and/or ketonuria

    Time frame: Day of delivery

  3. Maternal morbidity

    Time frame: Day of delivery

  4. Fetal morbidity

    Time frame: 1 month after delivery

Sponsors and collaborators

Lead sponsor

Hospital Arnau de Vilanova

Other

Registry information

Official study title

Comparison of Two Different Diets Containing Different Proportions of Carbohydrates in the Treatment of Gestational Diabetes Mellitus: A Randomized Clinical Trial

Acronym: LO-CA

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 1, 2009
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.