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

Diabetes in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028506
• Other study ID #: 25217
• Status: Completed
• Phase: N/A
• First received: January 19, 2017
• Last updated: September 21, 2017
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2017
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes in Pregnancy
• Diabetes, Gestational
• Pregnancy in Diabetics

Intervention

Other:
• Carbohydrate intake
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	large for gestational age infants	weight at birth	1 year