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

NCT02154997 | Unknown

• 1 other identifier: HMO-0071-14
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes; Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Uri Elchalal: lead

Study Sites (1)

Hadassah Ein Kerem

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ram Weiss, Md PhD

  Hebrew Universtity

  PRINCIPAL INVESTIGATOR

• Karen J Hershkop, PhD

  Hebrew University

  PRINCIPAL INVESTIGATOR

• Limor Marko, MSc

  Hebrew University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uriel Elchalal, MD

CONTACT

uriel@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Obstetrics and Gynecology Dept

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

IL (1)