Carbohydrate Restriction for Gestational Diabetes Mellitus (LO-CA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marta Hernández García, Hospital Arnau de Vilanova
ClinicalTrials.gov Identifier:
NCT00911404
First received: May 28, 2009
Last updated: July 15, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Gestational Diabetes Mellitus (GDM)
Behavioral: Low CHO
Dietary Supplement: High CHO diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Two Different Diets Containing Different Proportions of Carbohydrates in the Treatment of Gestational Diabetes Mellitus: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital Arnau de Vilanova:

Primary Outcome Measures:
  • Need of insulin treatment for GDM [ Time Frame: Day of delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from GDM diagnosis free of insulin treatment [ Time Frame: Day of delivery ] [ Designated as safety issue: No ]
  • Maternal ketonemia and/or ketonuria [ Time Frame: Day of delivery ] [ Designated as safety issue: No ]
  • Maternal morbidity [ Time Frame: Day of delivery ] [ Designated as safety issue: No ]
  • Fetal morbidity [ Time Frame: 1 month after delivery ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: January 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low CHO
Diet with 40% total calories from carbohydrates.
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.
Active Comparator: High CHO
Diet with 55% total calories from carbohydrates.
Dietary Supplement: High CHO diet
Diet with 55% total calories from carbohydrates.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911404

Locations
Spain
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Sponsors and Collaborators
Hospital Arnau de Vilanova
Investigators
Study Director: Didac Mauricio, MD PhD Hospital Universitari Arnau de Vilanova
Principal Investigator: Marta Hernández, MD Hospital Universitari Arnau de Vilanova
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marta Hernández García, MD, Hospital Arnau de Vilanova
ClinicalTrials.gov Identifier: NCT00911404     History of Changes
Other Study ID Numbers: CEIC-670
Study First Received: May 28, 2009
Last Updated: July 15, 2012
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Hospital Arnau de Vilanova:
Gestational diabetes
Carbohydrate
Diet
Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on September 18, 2014