NCT00911404

Carbohydrate Restriction for Gestational Diabetes Mellitus

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Hospital Arnau de Vilanova · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Diabetes Mellitus (GDM)

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	High CHO diet	Diet with 55% total calories from carbohydrates.

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-06-01
• Last updated: 2016-08-23

Locations

1 site across 1 country: Spain