Carbohydrate Restriction for Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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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.

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

Conditions
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Gestational Diabetes Mellitus (GDM)

Intervention / Treatment
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* Behavioral: Low CHO
* Dietary Supplement: High CHO diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low CHO<br>Diet with 40% total calories from carbohydrates. | Behavioral: Low CHO<br>* Diet with 40% total calories from carbohydrates. In the Low-CHO arm, 15% of calories from carbohydrates will be substituted by monounsaturated fat.<br>|
| Active Comparator: High CHO<br>Diet with 55% total calories from carbohydrates. | Dietary Supplement: High CHO diet<br>* Diet with 55% total calories from carbohydrates.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of insulin treatment for GDM |  | Day of delivery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational diabetes, Carbohydrate, Diet, Insulin