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

NCT ID: NCT01620125

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-12-31

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.

Conditions

Type 2 Diabetes; Insulin Resistance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lactobacillus reuteri

Dietary supplementation with Lactobacillus reuteri DSM 17938

Group Type: OTHER

Lactobacillus reuteri DSM 17938

Intervention Type: DIETARY_SUPPLEMENT

Ordinary treatment against type 2 diabetes is supplemented with one tablet containing 100 million Lactobacillus reuteri DSM 17398, once daily for 12 weeks

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per-Anders E jansson, Adj prof

Role: PRINCIPAL_INVESTIGATOR

The Wallenberg Laboratory, Bruna Stråket 16, Sahlgrenska University Hospital S-413 45 Gothenburg, Sweden

Fredrik Bäckhed, Assoc prof

Role: STUDY_CHAIR

The Wallenberg Laboratory, Bruna Stråket 16, Sahlgrenska University Hospital, S-413 45 Gothenburg, Sweden

Locations

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

Gothenburg, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 17210919 (View on PubMed)

Other Identifiers

Lactobacillus reuteri pilot

Identifier Type: -

Identifier Source: org_study_id