NCT03028506

Brief Summary

The purpose of the proposed study is to assess the distribution of carbohydrates and fat in the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The carbohydrate distribution and fat content of the meal will be compared to maternal glucose control, preprandial glucose levels, and the percentile for weight of the infant at birth. In addition, each meal and snack will be classified as low-moderate fat or high fat.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

January 19, 2017

Last Update Submit

September 21, 2017

Conditions

Diabetes in Pregnancy

Outcome Measures

Primary Outcomes (1)

  • large for gestational age infants

    weight at birth

    1 year

Interventions

Carbohydrate intakeOTHER

By calculating carbohydrate amounts at meals and snacks, as well as classifying meals and snacks as high fat, the investigators will examine the correlation to higher preprandial blood glucose values and large for gestational age infants.

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant, all ethnic groups

You may qualify if:

  • Female, age 16-45, all ethnic groups,
  • Type 1 diabetes
  • Blood glucose logs at least 75% complete
  • Food intake records during weeks 29-32 that are at least 75% complete

You may not qualify if:

  • Maternal medical conditions:
  • Renal disease
  • Restrictive lung disease
  • Cyanotic heart disease (severe heart disease where mother is blue)
  • Antiphospholipid antibody syndrome
  • Collagen-vascular disease (lupus)
  • Substance use and abuse (drugs)
  • Multiple gestation
  • Genetic disorders
  • Severe malnutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Officials

  • Rosemary Catanzaro, RD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 23, 2017

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 25, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share