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Carbohydrate Restriction for Gestational Diabetes Mellitus (LO-CA)

Primary Purpose

Gestational Diabetes Mellitus (GDM)

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Low CHO
High CHO diet
Sponsored by
Hospital Arnau de Vilanova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus (GDM) focused on measuring Gestational diabetes, Carbohydrate, Diet, Insulin

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Hospital Universitari Arnau de Vilanova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low CHO

High CHO

Arm Description

Diet with 40% total calories from carbohydrates.

Diet with 55% total calories from carbohydrates.

Outcomes

Primary Outcome Measures

Need of insulin treatment for GDM

Secondary Outcome Measures

Time from GDM diagnosis free of insulin treatment
Maternal ketonemia and/or ketonuria
Maternal morbidity
Fetal morbidity

Full Information

First Posted
May 28, 2009
Last Updated
August 20, 2016
Sponsor
Hospital Arnau de Vilanova
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1. Study Identification

Unique Protocol Identification Number
NCT00911404
Brief Title
Carbohydrate Restriction for Gestational Diabetes Mellitus
Acronym
LO-CA
Official Title
Comparison of Two Different Diets Containing Different Proportions of Carbohydrates in the Treatment of Gestational Diabetes Mellitus: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Arnau de Vilanova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus (GDM)
Keywords
Gestational diabetes, Carbohydrate, Diet, Insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low CHO
Arm Type
Experimental
Arm Description
Diet with 40% total calories from carbohydrates.
Arm Title
High CHO
Arm Type
Active Comparator
Arm Description
Diet with 55% total calories from carbohydrates.
Intervention Type
Behavioral
Intervention Name(s)
Low CHO
Intervention Description
Diet with 40% total calories from carbohydrates. In the "Low-CHO" arm, 15% of calories from carbohydrates will be substituted by monounsaturated fat.
Intervention Type
Dietary Supplement
Intervention Name(s)
High CHO diet
Intervention Description
Diet with 55% total calories from carbohydrates.
Primary Outcome Measure Information:
Title
Need of insulin treatment for GDM
Time Frame
Day of delivery
Secondary Outcome Measure Information:
Title
Time from GDM diagnosis free of insulin treatment
Time Frame
Day of delivery
Title
Maternal ketonemia and/or ketonuria
Time Frame
Day of delivery
Title
Maternal morbidity
Time Frame
Day of delivery
Title
Fetal morbidity
Time Frame
1 month after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didac Mauricio, MD PhD
Organizational Affiliation
Hospital Universitari Arnau de Vilanova
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marta Hernández, MD
Organizational Affiliation
Hospital Universitari Arnau de Vilanova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
18058723
Citation
Cypryk K, Kaminska P, Kosinski M, Pertynska-Marczewska M, Lewinski A. A comparison of the effectiveness, tolerability and safety of high and low carbohydrate diets in women with gestational diabetes. Endokrynol Pol. 2007 Jul-Aug;58(4):314-9.
Results Reference
background
PubMed Identifier
1748252
Citation
Peterson CM, Jovanovic-Peterson L. Percentage of carbohydrate and glycemic response to breakfast, lunch, and dinner in women with gestational diabetes. Diabetes. 1991 Dec;40 Suppl 2:172-4. doi: 10.2337/diab.40.2.s172.
Results Reference
background
PubMed Identifier
9540949
Citation
Major CA, Henry MJ, De Veciana M, Morgan MA. The effects of carbohydrate restriction in patients with diet-controlled gestational diabetes. Obstet Gynecol. 1998 Apr;91(4):600-4. doi: 10.1016/s0029-7844(98)00003-9.
Results Reference
background
PubMed Identifier
23564917
Citation
Moreno-Castilla C, Hernandez M, Bergua M, Alvarez MC, Arce MA, Rodriguez K, Martinez-Alonso M, Iglesias M, Mateu M, Santos MD, Pacheco LR, Blasco Y, Martin E, Balsells N, Aranda N, Mauricio D. Low-carbohydrate diet for the treatment of gestational diabetes mellitus: a randomized controlled trial. Diabetes Care. 2013 Aug;36(8):2233-8. doi: 10.2337/dc12-2714. Epub 2013 Apr 5.
Results Reference
derived

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Carbohydrate Restriction for Gestational Diabetes Mellitus

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