Carbohydrate Restriction for Gestational Diabetes Mellitus (LO-CA)

Hospital Arnau de Vilanova

Status: Completed

Conditions: Gestational Diabetes Mellitus (GDM)

Treatments: Behavioral: Low CHO; Dietary Supplement: High CHO diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00911404

CEIC-670

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 2 patient groups

Low CHO

Experimental group

Description:

Diet with 40% total calories from carbohydrates.

Treatment:

Behavioral: Low CHO

High CHO

Active Comparator group

Description:

Diet with 55% total calories from carbohydrates.

Treatment:

Dietary Supplement: High CHO diet