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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02469558
Date of registration:	03/06/2015
Prospective Registration:	Yes
Primary sponsor:	Medical University of Graz
Public title:	Probiotics in Diabesity: A Pilot Study Diabesity
Scientific title:	Probiotics in Diabesity: A Pilot Study
Date of first enrolment:	September 2015
Target sample size:	41
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02469558
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Austria

Contacts

Name:	Vanessa Stadlbauer-Köllner, MD
Address:
Telephone:
Email:
Affiliation:	Medical University of Graz

Name:	Harald Sourij, MD
Address:
Telephone:
Email:
Affiliation:	Medical University of Graz

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant is willing and able to give informed consent for participation in the
study.

- Age above 18 years

- Type 2 diabetes

- BMI 30-40 kg/m²

- HbA1c = 6.5% (48 mmol/mol)

- Stable diabetes therapy over 6 months

- Person commits to the need for long-term follow-up

Exclusion Criteria:

- Type 1 diabetes mellitus

- Maturity Onset Diabetes of the Young (MODY)

- Secondary diabetes due to a specific disease or glucocorticoid therapy

- Pregnancy

- Hypothalamic cause of obesity, Cushing syndrome

- Major psychiatric diseases including diagnosed eating disorders, history of drug or
alcohol abuse

- History of bariatric surgery

- Use of probiotics (other than the study product)

- Antibiotic therapy within the last 4 weeks before inclusion

- Inflammatory bowel disease

- Pancreatitis

- Chronic non-steroidal anti-inflammatory drug (NSAID) treatment

- glucagon-like peptide-1 receptor agonist therapy or acarbose therapy

- Recent (less than 12 weeks) acute myocardial infarction or decompensated heart failure

- Recent (less than 12 weeks) stroke

- Known malignancy or any other condition or circumstance, which, in the opinion of the
investigator, would affect the patient's ability to participate in the protocol

Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Obesity

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Winclove 851 and 110

Primary Outcome(s)

insulin sensitivity [Time Frame: 12 months]

Secondary Outcome(s)

Secondary ID(s)

26-464 ex 13/14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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