Back to resultsThe Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients
Primary Purpose
Fasting Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
late night meal
Sponsored by
About this trial
This is an interventional treatment trial for Fasting Hyperglycemia
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
different types of bad time food
Arm Description
Different types of bad time food
Outcomes
Primary Outcome Measures
fasting glucose level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00986700
Brief Title
The Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients
Official Title
The Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasting Hyperglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
different types of bad time food
Arm Type
Other
Arm Description
Different types of bad time food
Intervention Type
Dietary Supplement
Intervention Name(s)
late night meal
Intervention Description
Three different kinds of late night meal each for 2 days.
Primary Outcome Measure Information:
Title
fasting glucose level
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
The Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients
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