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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Jacob Ilany MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00986700
First received: September 29, 2009
Last updated: June 18, 2017
Last verified: June 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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 Dr. Jacob Ilany MD, Sheba Medical Center:

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

Enrollment: 19
Study Start Date: October 2009
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Dr. Jacob Ilany MD, Senior Endocrinologist, 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: June 18, 2017

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 22, 2017