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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02154997
• Other study ID #: HMO-0071-14
• Status: Recruiting
• Phase: N/A
• First received: June 2, 2014
• Last updated: February 28, 2016
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: Hadassah Medical Organization
• Contact: Uriel Elchalal, MD
• Email: uriel[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Type 1 Diabetes
• Type 2 Diabetes

Locations

Country	Name	City	State
Israel	Hadassah Ein Kerem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Uri Elchalal

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post prandial blood glucose levels	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	No