Carbohydrate Restriction for Gestational Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-07-31

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.

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Detailed Description

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Conditions

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Gestational Diabetes Mellitus (GDM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low CHO

Diet with 40% total calories from carbohydrates.

Group Type EXPERIMENTAL

Low CHO

Intervention Type 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 with 55% total calories from carbohydrates.

Group Type ACTIVE_COMPARATOR

High CHO diet

Intervention Type DIETARY_SUPPLEMENT

Diet with 55% total calories from carbohydrates.

Interventions

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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.

Intervention Type BEHAVIORAL

High CHO diet

Diet with 55% total calories from carbohydrates.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No