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

NCT ID: NCT02154997

Last Updated: 2016-03-01

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Type 2 Diabetes Gestational Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 1 and Type 2 Diabetes

pregnant women which have a known condition of type 1 or type 2 diabetes

No interventions assigned to this group

Gestational diabetes

pregnant women which have developed Gestational diabetes

No interventions assigned to this group

Control group

Pregnant women whom do not suffer from any altered glucose metabolism

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Uri Elchalal

OTHER

Sponsor Role lead

Responsible Party

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Uri Elchalal

Associate Professor Obstetrics and Gynecology Dept

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ram Weiss, Md PhD

Role: PRINCIPAL_INVESTIGATOR

Hebrew Universtity

Karen J Hershkop, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebrew University

Limor Marko, MSc

Role: PRINCIPAL_INVESTIGATOR

Hebrew University

Locations

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Hadassah Ein Kerem

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Uriel Elchalal, MD

Role: CONTACT

Facility Contacts

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Uriel Elchalal, MD

Role: primary

Other Identifiers

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HMO-0071-14

Identifier Type: -

Identifier Source: org_study_id

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