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| Sponsors and Collaborators: |
The S. Daniel Abraham International Center for Health and Nutrition The Israeli Diabetes Research Group Itamar Raz, Hadassah Medical Center, Jerusalem, Israel Ilana Harman-Boham, Soroka Medical Center, Beer-Sheva, Israel Julio Vainstein, Wolfson Medical Center, Holon, Israel Tishbi Wines, Israel and Admiral Wine Imports, US Harvard University |
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| Information provided by: | The S. Daniel Abraham International Center for Health and Nutrition |
| ClinicalTrials.gov Identifier: | NCT00295334 |
Purpose
Our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: alcohol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | December 2006 |
Successful long-term control of hyperglycemia decreases the risk for diabetic complications . Although a family history of diabetes is an established risk factor for type 2 diabetes, lifestyle factors also play an important role in its cause . However, physicians are poorly informed about how their patients’ alcohol use affects risk for or management of diabetes. Moderate alcohol consumption has been associated with lower risk of both cardiovascular disease and type 2 diabetes, and is also linked to lower cardiovascular risk among type 2 diabetics. Potential mechanisms have focused primarily on lipid metabolism, coagulation, fibrinolysis, and insulin sensitivity. A recent systematic review of the literature to assess the effect of alcohol consumption on risk for and management and complications of diabetes mellitus suggests that moderate alcohol consumption is associated with a decreased risk for diabetes, whereas heavy alcohol consumption may be associated with an increased risk. Our aim is to assess the effect of moderate alcohol intake on glycemic control and cardiovascular disease mediators among patients with type 2 diabetes.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
5. Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).
6. Patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness. 7. Using drugs that might significantly interact with moderate alcohol. List of drugs will be obtained from pharmacology expert. 8. Presence of active cancer, receiving or had received chemotherapy in last 3 years.
9. Suffering a major illness that might probably require hospitalization (upon physician's evaluation).
10. Clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse.
11. Severe symptoms during run-in as assessed by the physician. 12. Pregnant or lactating women. 13. Participation in another trial in which active intervention is being received.
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Contacts and Locations| Principal Investigator: | Iris Shai, RD PhD | Ben-Gurion University of the Negev |
More Information
| Study ID Numbers: | 250505 |
| Study First Received: | February 21, 2006 |
| Last Updated: | September 11, 2006 |
| ClinicalTrials.gov Identifier: | NCT00295334 |
| Health Authority: | Israel: Ethics Commission |
|
adherence glycemic control |
|
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Endocrinopathy |
Metabolic disorder Glucose Metabolism Disorders Alcohol Drinking Ethanol |
