Carbohydrate Restriction for Gestational Diabetes Mellitus

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus (GDM)
• Interventions: Dietary Supplement: High CHO diet; Behavioral: Low CHO

• Registration Number: NCT00911404
• Lead Sponsor: Hospital Arnau de Vilanova

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-06-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-20
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High CHO	High CHO diet	Diet with 55% total calories from carbohydrates.
Low CHO	Low CHO	Diet with 40% total calories from carbohydrates.

Primary Outcome Measures

Name	Time	Method
Need of insulin treatment for GDM	Day of delivery

Secondary Outcome Measures

Name	Time	Method
Maternal morbidity	Day of delivery
Maternal ketonemia and/or ketonuria	Day of delivery
Time from GDM diagnosis free of insulin treatment	Day of delivery
Fetal morbidity	1 month after delivery

Trial Locations

Locations (1)

Hospital Universitari Arnau de Vilanova; 🇪🇸 Lleida, Spain