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The Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00986700
First received: September 29, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

High fasting glucose is a very common problem in type 2 diabetic patients. The cause is probably glucose production by the liver, known as the "dawn phenomenon". The investigators hypothesize that a late night meal can lower the fasting glucose level by early morning insulin secretion stimulated by the food. In this study the investigators intend to test the effect of different kinds of late night meals on fasting glucose in type 2 diabetic patients.


Condition Intervention
Fasting Hyperglycemia
 Dietary Supplement: late night meal

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • fasting glucose level [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: late night meal
    Three different kinds of late night meal each for 2 days.
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus with HbA1c 6.5-9%, fasting glucose of 126-200 mg/dl and BMI of 27-40.

Exclusion Criteria:

  • Patient treated with insulin, GLP-1 analog or weight reduction medications.
  • Type 1 diabetes
  • Pregnancy
  • Renal failure (creatinin >1.4 for male and 1.3 for female
  • Uncontrolled hypertension (>160/100)
  • Abnormal thyroid function test
  • Patient treated with steroids or psychiatric medications.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jacob Ilany MD, sheba medical center
ClinicalTrials.gov Identifier: NCT00986700     History of Changes
Other Study ID Numbers: SHEBA-09-7156-JI-CTIL
Study First Received: September 29, 2009
Last Updated: September 29, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hyperglycemia
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013