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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. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Sheba Medical Center Identifier:
First received: September 29, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
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: 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

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • fasting glucose level [ Time Frame: 2 weeks ]

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.

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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No Contacts or Locations Provided
  More Information

Responsible Party: Jacob Ilany MD, sheba medical center 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

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases processed this record on April 27, 2017