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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00911404

Acronym

LO-CA

Enrollment

152

Registered

2009-06-01

Start date

2009-01-31

Completion date

2012-07-31

Last updated

2016-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

Gestational diabetes, Carbohydrate, Diet, Insulin

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.

Interventions

BEHAVIORALLow 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_SUPPLEMENTHigh CHO diet

Diet with 55% total calories from carbohydrates.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Need of insulin treatment for GDM	Day of delivery

Secondary

Measure	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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026