NCT00911404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

3.5 years

First QC Date

May 28, 2009

Last Update Submit

August 20, 2016

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

Gestational diabetesCarbohydrateDietInsulin

Outcome Measures

Primary Outcomes (1)

  • Need of insulin treatment for GDM

    Day of delivery

Secondary Outcomes (4)

  • 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

Study Arms (2)

Low CHO

EXPERIMENTAL

Diet with 40% total calories from carbohydrates.

Behavioral: Low CHO

High CHO

ACTIVE COMPARATOR

Diet with 55% total calories from carbohydrates.

Dietary Supplement: High CHO diet

Interventions

Low CHOBEHAVIORAL

Diet with 40% total calories from carbohydrates. In the "Low-CHO" arm, 15% of calories from carbohydrates will be substituted by monounsaturated fat.

Low CHO
High CHO dietDIETARY_SUPPLEMENT

Diet with 55% total calories from carbohydrates.

High CHO

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational diabetes mellitus
  • Single pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Arnau de Vilanova

Lleida, Lleida, 25198, Spain

Location

Related Publications (4)

  • 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.

    PMID: 18058723BACKGROUND

  • 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.

    PMID: 1748252BACKGROUND

  • 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.

    PMID: 9540949BACKGROUND

  • 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.

    PMID: 23564917DERIVED

MeSH Terms

Conditions

Diabetes, GestationalInsulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Didac Mauricio, MD PhD

    Hospital Universitari Arnau de Vilanova

    STUDY DIRECTOR

  • Marta Hernández, MD

    Hospital Universitari Arnau de Vilanova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 23, 2016

Record last verified: 2016-08

Locations

ES(1)