Trial Outcomes & Findings for Moderate Alcohol Intake Among Patients With Type 2 Diabetes (NCT NCT00295334)
NCT ID: NCT00295334
Last Updated: 2025-06-24
Results Overview
A change from baseline to 3-month time points is reported
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
Differance between 3 month time point minus baseline
Results posted on
2025-06-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
75
|
|
Overall Study
Chosen Wine (Red, n)
|
0
|
56
|
|
Overall Study
COMPLETED
|
25
|
66
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Moderate Alcohol Intake Among Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Alcohol
n=75 Participants
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.
|
Control
n=34 Participants
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.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 6.9 • n=99 Participants
|
61.1 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
61.1 years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
75 participants
n=99 Participants
|
34 participants
n=107 Participants
|
109 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Differance between 3 month time point minus baselineA change from baseline to 3-month time points is reported
Outcome measures
| Measure |
Alcohol
n=75 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
Glucose
|
-21.55 mg/dL
Standard Deviation 41.18
|
1.92 mg/dL
Standard Deviation 25.69
|
PRIMARY outcome
Timeframe: Adherence at 3-months (end of intervention)Count of participants that finished the 3-month intervention
Outcome measures
| Measure |
Alcohol
n=75 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
Adherence
|
66 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: Differance between 3 month time point minus baselineA change from baseline to 3-month time points is reported
Outcome measures
| Measure |
Alcohol
n=75 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
HbA1c
|
-0.29 % of HbA1c
Standard Deviation 0.99
|
-0.24 % of HbA1c
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: A change from baseline to 3-month time points is reportedDifferance between 3 month time point minus baseline
Outcome measures
| Measure |
Alcohol
n=75 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
LDL, HDL, TG
HDL
|
-2.34 mg/dl
Standard Deviation 9.85
|
-3.0 mg/dl
Standard Deviation 4.55
|
|
LDL, HDL, TG
TG
|
23.05 mg/dl
Standard Deviation 81.10
|
10.40 mg/dl
Standard Deviation 87.86
|
|
LDL, HDL, TG
LDL
|
-11.53 mg/dl
Standard Deviation 29.22
|
0.12 mg/dl
Standard Deviation 24.03
|
Adverse Events
Alcohol
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alcohol
n=75 participants at risk
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.
|
Control
n=34 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
gastric pain
|
1.3%
1/75
|
0.00%
0/34
|
|
General disorders
illness
|
2.7%
2/75
|
2.9%
1/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place