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| Name | Class |
|---|---|
| The Israeli Diabetes Research Group | UNKNOWN |
| Hadassah Medical Organization | OTHER |
| Soroka University Medical Center | OTHER |
| Julio Vainstein, Wolfson Medical Center, Holon, Israel |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean diet + red wine | Active Comparator |
| |
| Mediterranean diet + white wine | Active Comparator |
| |
| Mediterranean diet+ mineral water | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alcohol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | A change from baseline to 3-month time points is reported | Differance between 3 month time point minus baseline |
| Adherence | Count of participants that finished the 3-month intervention | Adherence at 3-months (end of intervention) |
| HbA1c | A change from baseline to 3-month time points is reported | Differance between 3 month time point minus baseline |
| Measure | Description | Time Frame |
|---|---|---|
| LDL, HDL, TG | Differance between 3 month time point minus baseline | A change from baseline to 3-month time points is reported |
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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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| Name | Affiliation | Role |
|---|---|---|
| Iris Shai, RD PhD | Ben-Gurion University of the Negev | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17848609 | Derived | Shai I, Wainstein J, Harman-Boehm I, Raz I, Fraser D, Rudich A, Stampfer MJ. Glycemic effects of moderate alcohol intake among patients with type 2 diabetes: a multicenter, randomized, clinical intervention trial. Diabetes Care. 2007 Dec;30(12):3011-6. doi: 10.2337/dc07-1103. Epub 2007 Sep 11. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to <7% of total calories and minimization of trans fat), and 15-20% from protein. Participants randomly assigned to the control group were instructed to drink 150 ml of the nonalcoholic diet malt beer we provided, using the same standard measured glass, during dinner. |
| FG001 | Alcohol | All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to <7% of total calories and minimization of trans fat), and 15-20% from protein. the alcohol group was instructed to reduce carbohydrates by 100 kcal, but not at dinner, to decrease the likelihood of alcohol-induced hypoglycemia. Patients assigned to consume alcohol were instructed to start drinking gradually (over a 2-week period) 150 ml of wine (13% alcohol, 13 g) that we provided, using a standard measured glass, during dinner. The patients could choose either dry red (Merlot) or white (Sauvignon Blanc) wine. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol | All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to <7% of total calories and minimization of trans fat), and 15-20% from protein. the alcohol group was instructed to reduce carbohydrates by 100 kcal, but not at dinner, to decrease the likelihood of alcohol-induced hypoglycemia. Patients assigned to consume alcohol were instructed to start drinking gradually (over a 2-week period) 150 ml of wine (13% alcohol, 13 g) that we provided, using a standard measured glass, during dinner. The patients could choose either dry red (Merlot) or white (Sauvignon Blanc) wine; 75% chose red wine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glucose | A change from baseline to 3-month time points is reported | Posted | Mean | Standard Deviation | mg/dL | Differance between 3 month time point minus baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alcohol | All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to <7% of total calories and minimization of trans fat), and 15-20% from protein. the alcohol group was instructed to reduce carbohydrates by 100 kcal, but not at dinner, to decrease the likelihood of alcohol-induced hypoglycemia. Patients assigned to consume alcohol were instructed to start drinking gradually (over a 2-week period) 150 ml of wine (13% alcohol, 13 g) that we provided, using a standard measured glass, during dinner. The patients could choose either dry red (Merlot) or white (Sauvignon Blanc) wine; 75% chose red wine. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastric pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Iris Shai | Ben-Gurion University of the Negev | +972086477443 | irish@bgu.ac.il |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| UNKNOWN |
| Tishbi Wines, Israel and Admiral Wine Imports, US | UNKNOWN |
| Harvard University | OTHER |
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| BG001 | Control | All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to <7% of total calories and minimization of trans fat), and 15-20% from protein. Participants randomly assigned to the control group were instructed to drink 150 ml of the nonalcoholic diet malt beer we provided, using the same standard measured glass, during dinner. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to <7% of total calories and minimization of trans fat), and 15-20% from protein. Participants randomly assigned to the control group were instructed to drink 150 ml of the nonalcoholic diet malt beer we provided, using the same standard measured glass, during dinner. |
|
|
| Primary | Adherence | Count of participants that finished the 3-month intervention | Posted | Count of Participants | Participants | Adherence at 3-months (end of intervention) |
|
|
|
| Primary | HbA1c | A change from baseline to 3-month time points is reported | Posted | Mean | Standard Deviation | % of HbA1c | Differance between 3 month time point minus baseline |
|
|
|
| Secondary | LDL, HDL, TG | Differance between 3 month time point minus baseline | Posted | Mean | Standard Deviation | mg/dl | A change from baseline to 3-month time points is reported |
|
|
|
| 0 |
| 75 |
| 3 |
| 75 |
| EG001 | Control | All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to <7% of total calories and minimization of trans fat), and 15-20% from protein. Participants randomly assigned to the control group were instructed to drink 150 ml of the nonalcoholic diet malt beer we provided, using the same standard measured glass, during dinner. | 0 | 34 | 1 | 34 |
| illness | General disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| TG |
|