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

Type 2 Diabetes Clinical Trial

Official title:

Metabolic Control of Type 2 Diabetes Patients Before and After Dietary Supplementation With the Probiotic Lactobacillus Reuteri DSM 17938 - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620125
• Other study ID #: Lactobacillus reuteri pilot
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2020
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Sweden	Gothia Forum, CTC, Gröna Stråket 12, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Bäckhed 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. Epub 2007 Jan 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 weeks
Secondary	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.	12 weeks