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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00986700
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : June 20, 2017
Information provided by (Responsible Party):
Dr. Jacob Ilany MD, Sheba Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Fasting Hyperglycemia Dietary Supplement: late night meal Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients
Study Start Date : October 2009
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
different types of bad time food
Different types of bad time food
Dietary Supplement: late night meal
Three different kinds of late night meal each for 2 days.

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

Information from the National Library of Medicine

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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.

Responsible Party: Dr. Jacob Ilany MD, Senior Endocrinologist, Sheba Medical Center Identifier: NCT00986700     History of Changes
Other Study ID Numbers: SHEBA-09-7156-JI-CTIL
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases