Carbohydrate Restriction for Gestational Diabetes Mellitus (LO-CA)

August 20, 2016 updated by: Marta Hernández García, Hospital Arnau de Vilanova

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Lleida, Spain, 25198
        • Hospital Universitari Arnau de Vilanova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low CHO
Diet with 40% total calories from carbohydrates.
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.
Active Comparator: High CHO
Diet with 55% total calories from carbohydrates.
Dietary supplement: High CHO diet
Diet with 55% total calories from carbohydrates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Need of insulin treatment for GDM
Time Frame: Day of delivery
Day of delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from GDM diagnosis free of insulin treatment
Time Frame: Day of delivery
Day of delivery
Maternal ketonemia and/or ketonuria
Time Frame: Day of delivery
Day of delivery
Maternal morbidity
Time Frame: Day of delivery
Day of delivery
Fetal morbidity
Time Frame: 1 month after delivery
1 month after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Arnau de Vilanova

Investigators

  • Study Director: Didac Mauricio, MD PhD, Hospital Universitari Arnau de Vilanova
  • Principal Investigator: Marta Hernández, MD, Hospital Universitari Arnau de Vilanova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (Estimate)

June 1, 2009

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 20, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC-670

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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