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

Meal Composition and Frequency in Type 1 Diabetic Women and the Influence on Pre-prandial Blood Glucose Values and Fetal Weight.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes in Pregnancy
• Intervention / Treatment: Other: Carbohydrate intake

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 Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant, all ethnic groups

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
large for gestational age infants	weight at birth	1 year

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Rosemary Catanzaro, RD, St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 25217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No