Phase 2
N=109
Moderate Alcohol Intake Among Patients With Type 2 Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00295334 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Glucose — -21.55; 1.92 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- alcohol (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Iris Shai
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose |
-21.55; 1.92 | — |
| PRIMARY Adherence |
66; 25 | — |
| PRIMARY HbA1c |
-0.29; -0.24 | — |
| SECONDARY LDL, HDL, TG |
-11.53; 0.12; -2.34; -3.0; 23.05; 10.40 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age between 40-75 yrs.
- Alcohol abstainers (less than or equal to 1 drink/week)
- Established diagnosis of type 2 diabetes.
- Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.
Exclusion Criteria
- Taking Insulin >2 injections /day, or with insulin pump.
- TGs>500 mg/dL.
- HbA1c >10%
- Serum creatinine > 2 mg/dl
- Liver dysfunction (above 2 fold level of ALT and/or AST enzymes)
- Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).
- 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.
- Suffering a major illness that might probably require hospitalization (upon physician's evaluation).
- 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.
- 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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Data sourced from ClinicalTrials.gov (NCT00295334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.