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

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.

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Key information

Conditions

Diabetes in Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

16 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate intake

Other

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.

Primary outcomes

large for gestational age infants

Time frame: 1 year

weight at birth

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jan 23, 2017
Registry last updated: Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed