Meal Composition and the Influence on Pre-prandial Blood Glucose Values

Completed

• Conditions: Diabetes in Pregnancy

• Registration Number: NCT03028506
• Lead Sponsor: St. Louis University

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.

Detailed Description

This is a retrospective chart review. Data will be collected on all patients seen whose blood sugar and food logs were at least 75% complete. By calculating carbohydrate amounts at meals and snacks, as well as classifying meals and snacks as high fat, we will examine the correlation to higher preprandial blood glucose values and large for gestational age infants. Preprandial glucose levels will be reviewed, questioning whether the biggest contributor is the composition of the previous meal or additional snacks between meals.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
large for gestational age infants	1 year	weight at birth