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

Vastra Gotaland Region

Status and phase: Completed; Early Phase 1

Conditions: Insulin Resistance; Type 2 Diabetes

Treatments: Dietary Supplement: Lactobacillus reuteri DSM 17938

Study type: Interventional

Funder types: Other

Identifiers

NCT01620125

Lactobacillus reuteri pilot

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Lactobacillus reuteri

Other group

Description:

Dietary supplementation with Lactobacillus reuteri DSM 17938

Treatment:

Dietary Supplement: Lactobacillus reuteri DSM 17938