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

Primary Purpose

Type 2 Diabetes, Insulin Resistance

Status
Completed
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Lactobacillus reuteri DSM 17938
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Lactobacillus, Gut microbiota, Diabetes mellitus

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gothia Forum, CTC, Gröna Stråket 12, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lactobacillus reuteri

Arm Description

Dietary supplementation with Lactobacillus reuteri DSM 17938

Outcomes

Primary Outcome Measures

HOMA index
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
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.

Full Information

First Posted
June 12, 2012
Last Updated
February 10, 2020
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT01620125
Brief Title
Metabolic Control Before and After Supplementation With Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes Patients
Official Title
Metabolic Control of Type 2 Diabetes Patients Before and After Dietary Supplementation With the Probiotic Lactobacillus Reuteri DSM 17938 - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Insulin Resistance
Keywords
Lactobacillus, Gut microbiota, Diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus reuteri
Arm Type
Other
Arm Description
Dietary supplementation with Lactobacillus reuteri DSM 17938
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri DSM 17938
Intervention Description
Ordinary treatment against type 2 diabetes is supplemented with one tablet containing 100 million Lactobacillus reuteri DSM 17398, once daily for 12 weeks
Primary Outcome Measure Information:
Title
HOMA index
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in diabetes medication and hypoglycemia events
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per-Anders E jansson, Adj prof
Organizational Affiliation
The Wallenberg Laboratory, Bruna Stråket 16, Sahlgrenska University Hospital S-413 45 Gothenburg, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fredrik Bäckhed, Assoc prof
Organizational Affiliation
The Wallenberg Laboratory, Bruna Stråket 16, Sahlgrenska University Hospital, S-413 45 Gothenburg, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Gothia Forum, CTC, Gröna Stråket 12, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
S-413 45
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
17210919
Citation
Backhed F, Manchester JK, Semenkovich CF, Gordon JI. Mechanisms underlying the resistance to diet-induced obesity in germ-free mice. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):979-84. doi: 10.1073/pnas.0605374104. Epub 2007 Jan 8.
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Metabolic Control Before and After Supplementation With Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes Patients

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