NCT04051359

Brief Summary

The purpose of this controlled, randomized intervention is to investigate whether a carbohydrate-restricted diet, having a positive effect on blood sugar and weigh maintaining in diabetes, is effective and safe for pregnant woman with GDM and safe for their offspring, when compared to the standard carbohydrate content diet.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

August 15, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

August 8, 2019

Last Update Submit

August 8, 2019

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • The rate of treatment failure defined as patients needing additional hypoglycemic therapy by long-insulin acting analogue detemir evaluated by capillary glucose levels

    o The treatment failure would be defined if the fasting SMBG would be ≥95 mg/dl and/or if 1-hour post-prandial (PP) BG would be ≥140 mg/dl or 2 hour PP BG would be ≥120 mg/dl in \>20% of the measurements

    From one week after inclusion : 13 to 36 weeks of gestation to delivery

Study Arms (2)

Standard carbohydrate (200 g) group

ACTIVE COMPARATOR

Assignment to treatment groups will be performed on the enrollment to the study by evaluating the dietary carbohydrate intake personal patient preferences from 3 days prospective 24 hours' food dairy. After, the randomization will be performed and GDM patients will be assigned to the standard carbohydrate (200 g) group.

Other: Low carbohydrate (130 g) diet

Low carbohydrate (130 g) group

EXPERIMENTAL

Assignment to treatment groups will be performed on the enrollment to the study by evaluating the dietary carbohydrate intake personal patient preferences from 3 days prospective 24 hours' food dairy. After, the randomization will be performed and GDM patients will be assigned to the low carbohydrate (130 g) group.

Other: Low carbohydrate (130 g) diet

Interventions

Low carbohydrate (130 g) dietOTHER

Isocaloric moderately reduced carbohydrate diet (RCD, reduced carbohydrate diet) (\~130 grams of carbohydrates)

Low carbohydrate (130 g) groupStandard carbohydrate (200 g) group

Eligibility Criteria

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

You may qualify if:

  • Ages 18-45 years
  • GDM diagnosed between 12 and 34 weeks gestation according to Carpenter and Coustan criteria (13)
  • BMI 20-35 kg/m2
  • Singleton pregnancy
  • Willing to perform self-monitoring of blood glucose at least 4 times a day
  • Self-monitoring of blood glucose
  • to 34 weeks of gestation at the time of randomization
  • Signed informed consent

You may not qualify if:

  • Pre-existing diabetes in pregnancy, including first trimester fasting glucose ≥105 mg/dL
  • Use of other oral hypoglycemic agents during this pregnancy
  • Multiple pregnancy
  • Known hepatic insufficiency (bilirubin \>50 µmol/L and/or protrombin time \<50 %)
  • Insufficient understanding
  • Fetal malformation diagnosed by previous fetal ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Metabolism and Hypertension, Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PA

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 9, 2019

Study Start

August 15, 2019

Primary Completion

February 15, 2021

Study Completion

August 15, 2021

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

IL(1)