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

Early Phase 1

Completed

• Conditions: Type 2 Diabetes; Insulin Resistance
• Interventions: Dietary Supplement: Lactobacillus reuteri DSM 17938

• Registration Number: NCT01620125
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-15
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lactobacillus reuteri	Lactobacillus reuteri DSM 17938	Dietary supplementation with Lactobacillus reuteri DSM 17938

Primary Outcome Measures

Name	Time	Method
HOMA index	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).

Secondary Outcome Measures

Name	Time	Method
Changes in diabetes medication and hypoglycemia events	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.

Trial Locations

Locations (1)

Gothia Forum, CTC, Gröna Stråket 12, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden