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

NCT ID: NCT03028506

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes in Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Louis University

OTHER

Sponsor Role lead

Responsible Party

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Rosemary Catanzaro, RD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rosemary Catanzaro, RD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Other Identifiers

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25217

Identifier Type: -

Identifier Source: org_study_id