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

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

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 baseline

A change from baseline to 3-month time points is reported

Outcome measures

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

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 baseline

A change from baseline to 3-month time points is reported

Outcome measures

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 reported

Differance between 3 month time point minus baseline

Outcome measures

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

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

Iris Shai

Ben-Gurion University of the Negev

Phone: +972086477443

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place