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Carbohydrate Restriction for Gestational Diabetes Mellitus (LO-CA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00911404
First Posted: June 1, 2009
Last Update Posted: August 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marta Hernández García, Hospital Arnau de Vilanova
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Further study details as provided by Marta Hernández García, Hospital Arnau de Vilanova:

Primary Outcome Measures:
  • Need of insulin treatment for GDM [ Time Frame: Day of delivery ]

Secondary Outcome Measures:
  • Time from GDM diagnosis free of insulin treatment [ Time Frame: Day of delivery ]
  • Maternal ketonemia and/or ketonuria [ Time Frame: Day of delivery ]
  • Maternal morbidity [ Time Frame: Day of delivery ]
  • Fetal morbidity [ Time Frame: 1 month after delivery ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: May 28, 2009
First Posted: June 1, 2009
Last Update Posted: August 23, 2016
Last Verified: August 2016

Keywords provided by Marta Hernández García, 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