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Effect of Probiotic Supplements on Metabolic Control of People With Type 2 Diabetes Mellitus in Greece

NCT06032988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-30

No results posted yet for this study

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 probiotic dietary supplement capsule for 6 months compared to those not receiving such a treatment (they will receive a matching placebo capsule that does not contain active ingredients).

The main questions to answer are:

1. Will glycemic indices, i.e., glycated hemoglobin (HbA1c) and fasting blood glucose, be different in people taking the probiotic treatment, compared to those not taking it, after 6 months?
2. Will other metabolic indices, mostly blood lipid levels (total cholesterol, triglycerides, HDL- and LDL-cholesterol) and liver function tests, be different in people taking the probiotic treatment compared to those not taking it after 6 months?
3. Will adiposity measures (weight, waist circumference) be affected by probiotic treatment in the two groups? Studies in animals and humans, mostly of shorter duration (\<12 weeks) so far, have shown a possible trend towards improvement with probiotic treatment in all these parameters, but longer-term studies are scarce, and in Greece, there is none. Since diabetes treatment is complex (usually involving many medications) and expensive, developing cost-effective functional healthcare products for regulating blood glucose more efficiently has been recognized as a beneficial alternative.

Participants will be adult individuals (\>18 years old) with T2D, followed at the outpatient Diabetes Center of the Laiko General Hospital, National and Kapodistrian University of Athens Medical School, in Athens, Greece, who will be randomized to receive either a probiotic dietary supplement or a matching placebo capsule, once a day. They will be followed every 3 months (as is customary for diabetic patients). They will be monitored regarding their glycemic control (HbA1c and fasting blood glucose), lipid parameters, liver and renal function, and anthropometric changes (weight, waist circumference, and blood pressure). Furthermore, participants will be asked to give a stool sample at the study's beginning and end (6 months) for gut microbiota analysis. A questionnaire will also be administered at the last visit (6 months) asking about patients' tolerance and satisfaction with the treatment (frequency of constipation, diarrhea, bowel function, bloating, gas production, and abdominal pain).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DIETARY_SUPPLEMENT

LactoLevure

Participants will receive LactoLevure\^R probiotic dietary supplement or matching placebo once a day.

Sponsors & Collaborators

  • Uni-Pharma

    collaborator INDUSTRY

  • Konstantinos Makrilakis, MD

    lead OTHER

Principal Investigators

  • KONSTANTINOS MAKRILAKIS, MD, PhD · National and Kapodistrian University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2023-09-02
Completion
2023-09-02

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06032988 on ClinicalTrials.gov