The Effect of Different Food Products on Post Prandial Blood Glucose in Pregnant Woman With Diabetes

February 28, 2016 updated by: Uri Elchalal

During pregnancy nutrition demands change and the pregnant woman needs to adjust her food intake and take into consideration the corrected daily recommendations for micro and macro nutrients. Pregnant woman tend to suffer from hyperemesis and this affects their food choice.

Amongst pregnant women with Diabetes the glucose balance is extremely important during pregnancy. Glucose balance is a result of correct nutrition and an exact amount of insulin. This delicate balance requires from the pregnant women an ability to perform correct carbohydrate count.

Hyperglycemia has already been proven to affect the fetus and the neonatal outcomes. Hypoglycemia may also have a negative effect but the main danger is immediate harm to the mother and therefore to the fetus. For those reasons glucose balance is crucial and demands delicate synchronization of nutrition and insulin therapy.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women perticapting in this study will be from the high risk pregnancy clinic of hadassah Ein Kerem.

Description

Inclusion Criteria:

  • age 18-45
  • women who suffer from type 1 diabetes, type 2 diabetes or gestational diabetes
  • Do not suffer from any intestinal disease
  • Accept to sign a consent form

Exclusion Criteria:

  • over age of 45
  • under age of 18
  • suffer from any intestinal disease
  • do not accept to sign a consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Type 1 and Type 2 Diabetes
pregnant women which have a known condition of type 1 or type 2 diabetes
Gestational diabetes
pregnant women which have developed Gestational diabetes
Control group
Pregnant women whom do not suffer from any altered glucose metabolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post prandial blood glucose levels
Time Frame: The outcome will be measured at various time points during a 120 min OGTT: Fasting, 30, 60, 90 and 120 min
For every time point blood glucose will be analyzed for blood glucose and for Insulin and C-peptide for the control group
The outcome will be measured at various time points during a 120 min OGTT: Fasting, 30, 60, 90 and 120 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uri Elchalal

Investigators

  • Principal Investigator: Limor Marko, MSc, Hebrew University
  • Principal Investigator: Ram Weiss, Md PhD, Hebrew Universtity
  • Principal Investigator: Karen J Hershkop, PhD, Hebrew University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 2, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 4, 2014

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 28, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMO-0071-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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