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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02154997
Recruitment Status : Unknown
Verified February 2016 by Uri Elchalal, Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : June 4, 2014
Last Update Posted : March 1, 2016
Information provided by (Responsible Party):
Uri Elchalal, Hadassah Medical Organization

Brief Summary:

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.

Condition or disease
Type 1 Diabetes Type 2 Diabetes Gestational Diabetes

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : November 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women perticapting in this study will be from the high risk pregnancy clinic of hadassah Ein Kerem.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02154997

Contact: Uriel Elchalal, MD

Hadassah Ein Kerem Recruiting
Jerusalem, Israel, 91120
Contact: Uriel Elchalal, MD   
Sponsors and Collaborators
Uri Elchalal
Principal Investigator: Ram Weiss, Md PhD Hebrew Universtity
Principal Investigator: Karen J Hershkop, PhD Hebrew University
Principal Investigator: Limor Marko, MSc Hebrew University

Responsible Party: Uri Elchalal, Associate Professor Obstetrics and Gynecology Dept, Hadassah Medical Organization Identifier: NCT02154997     History of Changes
Other Study ID Numbers: HMO-0071-14
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pregnancy Complications