Metabolic Control Before and After Supplementation With Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes Patients

February 10, 2020 updated by: Vastra Gotaland Region

Metabolic Control of Type 2 Diabetes Patients Before and After Dietary Supplementation With the Probiotic Lactobacillus Reuteri DSM 17938 - a Pilot Study

Recent data suggest that the trillions of bacteria in the investigators gastrointestinal tracts (gut microbiota) can function as an environmental factor that modulates the amount of body fat. Obese individuals have an altered gut microbiota and germ-free mice are resistant to developing diet-induced obesity and have lower fasting insulin and glucose and improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus strain in fermented milk for 12 weeks reduced adiposity and body weight in obese adults, possibly by reducing lipid absorption and inflammatory status. However, there are no studies to the investigators knowledge that address whether probiotic supplementation improves glucose metabolism in type 2 diabetes patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, S-413 45
        • Gothia Forum, CTC, Gröna Stråket 12, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes with a duration > 6 months
  • Abdominal obesity
  • HbA1c 50-80 mmol/mol
  • Written informed consent
  • Stated availability throughout the study period

Exclusion Criteria:

  • Autoimmune diabetes eg type 1 diabetes
  • Psychiatric illness or cancer diagnosis
  • No foreseeable need of treatment with corticosteroids or antibiotics
  • Inflammatory bowel disease
  • Administration of antibiotics 4 weeks before inclusion
  • Administration of probiotics 2 weeks before inclusion
  • Participation in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Lactobacillus reuteri
Dietary supplementation with Lactobacillus reuteri DSM 17938
Dietary supplement: Lactobacillus reuteri DSM 17938
Ordinary treatment against type 2 diabetes is supplemented with one tablet containing 100 million Lactobacillus reuteri DSM 17398, once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOMA index
Time Frame: 12 weeks
To determine improved glucose handling and insulin sensitivity in adult type 2 diabetic patients supplemented with the probiotic L. reuteri DSM 17938 over a 12 week period, we assess insulin sensitivity via the HOMA index (fp-Glucose x fS-Insulin divided by 22.5).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in diabetes medication and hypoglycemia events
Time Frame: 12 weeks
We monitor changes in diabetes medication and hypoglycemia events. Dosages of medication with oral hypoglycemic agents and number of insulin units per 24 hrs and number of hypoglycemia events will be registered in diaries.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Per-Anders E jansson, Adj prof, The Wallenberg Laboratory, Bruna Stråket 16, Sahlgrenska University Hospital S-413 45 Gothenburg, Sweden
  • Study Chair: Fredrik Bäckhed, Assoc prof, The Wallenberg Laboratory, Bruna Stråket 16, Sahlgrenska University Hospital, S-413 45 Gothenburg, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (ESTIMATE)

June 15, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lactobacillus reuteri pilot

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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