NCT01836796

Brief Summary

Recent data suggest that the trillions of bacteria in 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 concentrations and shows an improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus Gasseri SBT2055 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 controlled studies to the investigators knowledge that address whether probiotic supplementation affects glucose metabolism. The investigators hypothesis is that supplementation of Lactobacillus reuteri DSM 17938 may improve metabolic control in type 2 diabetes patients. In addition, the investigators will explore possible mechanisms behind the antihyperglycemic action of Lactobacillus Reuteri.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

11 months

First QC Date

April 17, 2013

Last Update Submit

October 24, 2013

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    12 weeks compared to baseline

Secondary Outcomes (3)

  • Liver steatosis

    Baseline compared to 12 weeks

  • Insulin sensitivity in muscle, liver and adipose tissue

    Baseline compared to 12 weeks

  • Urine albumine excretion rate

    Baseline compared to 12 weeks

Study Arms (3)

Lactobacillus Reuteri low

ACTIVE COMPARATOR

100 million Lactobacillus Reuteri once daily

Dietary Supplement: Lactobacillus ReuteriDietary Supplement: Lactobacillus Reuteri DSM17938

Lactobacillus Reuteri High

ACTIVE COMPARATOR

10 billion Lactobacillus Reuteri once daily

Dietary Supplement: Lactobacillus ReuteriDietary Supplement: Lactobacillus Reuteri DSM17938

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Lactobacillus Reuteri DSM17938

Interventions

Lactobacillus ReuteriDIETARY_SUPPLEMENT

100 million Lactobacillus Reuteri once daily or 10 billion Lactobacillus Reuteri once daily for 12 weeks.

Lactobacillus Reuteri HighLactobacillus Reuteri low
Lactobacillus Reuteri DSM17938DIETARY_SUPPLEMENT

Powder corresponding to 100 million or 10 billion Lactobacillus Reuteri is added to water once daily for 12 weeks.

Lactobacillus Reuteri HighLactobacillus Reuteri lowPlacebo

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes with a duration \> 6 months
  • Adults 50- 75 years of age
  • Abdominal obesity (females waist \> 80 cm; males waist \> 94 cm)
  • HbA1c 50-90 mmol/mol
  • Anti-hyperglycemic treatment with lifestyle, oral agents and insulin
  • Written informed consent
  • Stated availability throughout the study period
  • Fasting C-peptide \> 0.27 nmol/l
  • BMI 25-40 kg/m2
  • Stable weight (± 5 kg) and HbA1c (± 5 mmol/mol) for 6 months

You may not qualify if:

  • Autoimmune diabetes eg type 1 diabetes
  • Psychiatric illness e g claustrophobia or alcoholism, cancer diagnosis and no foreseeable need of treatment with corticosteroids or antibiotics under the 12 week study period
  • Heavy nicotine users suggesting abstinence problems during the clamp
  • Anti-coagulation with warfarin
  • Ischemic heart disease with an event \< 6 months ago
  • Inflammatory bowel disease
  • Participation in other clinical trials
  • Other medical conditions, as judged by the screening doctor, that might jeopardize compliance to the protocol eg severe obesity interfering with access to peripheral veins
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Centre, Gröna Stråket 12, Sahlgrenska University Hospital

Gothenburg, S-413 45, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 22, 2013

Study Start

May 1, 2012

Primary Completion

April 1, 2013

Study Completion

July 1, 2013

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

SE(1)