Carbohydrate Restriction for Gestational Diabetes Mellitus

Gestational Diabetes Mellitus (GDM) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911404
• Other study ID #: CEIC-670
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: August 20, 2016
• Start date: January 2009
• Est. completion date: July 2012

Study information

• Verified date: August 2016
• Source: Hospital Arnau de Vilanova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus (GDM)

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Arnau de Vilanova	Lleida

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Arnau de Vilanova

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need of insulin treatment for GDM		Day of delivery	No
Secondary	Time from GDM diagnosis free of insulin treatment		Day of delivery	No
Secondary	Maternal ketonemia and/or ketonuria		Day of delivery	No
Secondary	Maternal morbidity		Day of delivery	No
Secondary	Fetal morbidity		1 month after delivery	No