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
Information provided by:
Sheba Medical Center
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.
Dietary Supplement: late night meal
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||The Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients
Primary Outcome Measures:
- fasting glucose level [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||October 2010 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||30 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Type 2 diabetes mellitus with HbA1c 6.5-9%, fasting glucose of 126-200 mg/dl and BMI of 27-40.
- Patient treated with insulin, GLP-1 analog or weight reduction medications.
- Type 1 diabetes
- 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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ClinicalTrials.gov processed this record on February 27, 2015
||Jacob Ilany MD, sheba medical center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 29, 2009
||September 29, 2009
||Israel: Israeli Health Ministry Pharmaceutical Administration