Type 2 Diabetes
Conditions
Keywords
adherence, glycemic control
Brief summary
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.
Detailed description
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.
Interventions
DRUGalcohol
Sponsors
The Israeli Diabetes Research Group
Hadassah Medical Organization
Soroka University Medical Center
Julio Vainstein, Wolfson Medical Center, Holon, Israel
Tishbi Wines, Israel and Admiral Wine Imports, US
Harvard University
Iris Shai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 40-75 yrs. 2. Alcohol abstainers (less than or equal to 1 drink/week) 3. Established diagnosis of type 2 diabetes. 4. Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.
Exclusion criteria
1. Taking Insulin \>2 injections /day, or with insulin pump. 2. TGs\>500 mg/dL. 3. HbA1c \>10% 4. Serum creatinine \> 2 mg/dl 5. Liver dysfunction (above 2 fold level of ALT and/or AST enzymes) 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Differance between 3 month time point minus baseline | A change from baseline to 3-month time points is reported |
| Glucose | Differance between 3 month time point minus baseline | A change from baseline to 3-month time points is reported |
| Adherence | Adherence at 3-months (end of intervention) | Count of participants that finished the 3-month intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL, HDL, TG | A change from baseline to 3-month time points is reported | Differance between 3 month time point minus baseline |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 75 |
| 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. | 34 |
| Total | 109 |
Baseline characteristics
| Characteristic | Alcohol | Control | Total |
|---|---|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 6.9 | 61.1 years STANDARD_DEVIATION 6.7 | 61.1 years STANDARD_DEVIATION 6.9 |
| Region of Enrollment Israel | 75 participants | 34 participants | 109 participants |
| Sex: Female, Male Female | 33 Participants | 13 Participants | 46 Participants |
| Sex: Female, Male Male | 42 Participants | 21 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 75 | 1 / 34 |
| serious Total, serious adverse events | 0 / 75 | 0 / 34 |
Outcome results
Primary
Adherence
Count of participants that finished the 3-month intervention
Time frame: Adherence at 3-months (end of intervention)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol | Adherence | 66 Participants |
| Control | Adherence | 25 Participants |
Primary
Glucose
A change from baseline to 3-month time points is reported
Time frame: Differance between 3 month time point minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol | Glucose | -21.55 mg/dL | Standard Deviation 41.18 |
| Control | Glucose | 1.92 mg/dL | Standard Deviation 25.69 |
Primary
HbA1c
A change from baseline to 3-month time points is reported
Time frame: Differance between 3 month time point minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol | HbA1c | -0.29 % of HbA1c | Standard Deviation 0.99 |
| Control | HbA1c | -0.24 % of HbA1c | Standard Deviation 0.86 |
Secondary
LDL, HDL, TG
Differance between 3 month time point minus baseline
Time frame: A change from baseline to 3-month time points is reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alcohol | LDL, HDL, TG | LDL | -11.53 mg/dl | Standard Deviation 29.22 |
| Alcohol | LDL, HDL, TG | HDL | -2.34 mg/dl | Standard Deviation 9.85 |
| Alcohol | LDL, HDL, TG | TG | 23.05 mg/dl | Standard Deviation 81.1 |
| Control | LDL, HDL, TG | LDL | 0.12 mg/dl | Standard Deviation 24.03 |
| Control | LDL, HDL, TG | HDL | -3.0 mg/dl | Standard Deviation 4.55 |
| Control | LDL, HDL, TG | TG | 10.40 mg/dl | Standard Deviation 87.86 |