Status:
COMPLETED
Effect of Probiotic Supplements on Metabolic Control of People With Type 2 Diabetes Mellitus in Greece
Lead Sponsor:
Konstantinos Makrilakis, MD
Collaborating Sponsors:
Uni-Pharma
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The goal of this interventional clinical study is to examine if there will be a change in metabolic indices (glycemic and lipid parameters) among persons with type 2 diabetes (T2D) who will receive a ...
Detailed Description
Eligible participants will be randomized using a computer generator (www.randomization.com), which randomizes each subject to a single treatment by using the method of randomly permuted blocks, to rec...
Eligibility Criteria
Inclusion
- T2D diagnosis of \>6 months' duration
- Age 18-90 years
- A body-mass index (BMI) \>18.5 kg/m\^2
- HbA1c level \>6 percent (%)
- on stable antidiabetic medications (oral or injectable glucagon-like peptide 1 receptor agonists \[GLP-1 RAs\]) for 8 weeks before the screening
Exclusion
- Type 1 or other type of diabetes
- Pregnancy or wishing to become pregnant during the study
- End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe hepatic insufficiency (transaminases \>3.5x above normal)
- The use of other probiotic products or antibiotics over the previous 6 months
- Participation in other clinical trials
- Insulin administration
- The presence of other medical conditions that in the opinion of the investigators could jeopardize compliance with the protocol (e.g., malabsorption syndrome or an inability to take orally administered medications)
Key Trial Info
Start Date :
August 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06032988
Start Date
August 23 2023
End Date
September 2 2023
Last Update
May 30 2025
Active Locations (1)
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1
Laiko General Hospital
Athens, Attica, Greece, 11526