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

This study is currently recruiting participants.
Verified June 2012 by Vastra Gotaland Region
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region
ClinicalTrials.gov Identifier:
NCT01620125
First received: June 12, 2012
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Insulin Resistance
Dietary Supplement: Lactobacillus reuteri DSM 17938
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Control of Type 2 Diabetes Patients Before and After Dietary Supplementation With the Probiotic Lactobacillus Reuteri DSM 17938 - a Pilot Study

Resource links provided by NLM:


Further study details as provided by Vastra Gotaland Region:

Primary Outcome Measures:
  • HOMA index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Changes in diabetes medication and hypoglycemia events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 12
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Lactobacillus reuteri DSM 17938

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620125

Contacts
Contact: Per-Anders E Jansson, Adj prof 46 31 342 10 00 ext 73 26 per-anders.jansson@medic.gu.se

Locations
Sweden
Gothia Forum, CTC, Gröna Stråket 12, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, S-413 45
Contact: Kaj Stenlöf, Director    46 708 76 01 30    kaj.stenlof@vgregion.se   
Sub-Investigator: Niklas Rydberg, MD         
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT01620125     History of Changes
Other Study ID Numbers: Lactobacillus reuteri pilot
Study First Received: June 12, 2012
Last Updated: June 14, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Vastra Gotaland Region:
Lactobacillus
Gut microbiota
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on April 23, 2014