NCT01620125

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1 type-2-diabetes

Timeline
Completed

Started May 2012

Shorter than P25 for early_phase_1 type-2-diabetes

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
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

June 12, 2012

Last Update Submit

February 10, 2020

Conditions

Type 2 DiabetesInsulin Resistance

Keywords

LactobacillusGut microbiotaDiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in diabetes medication and hypoglycemia events

    12 weeks

Study Arms (1)

Lactobacillus reuteri

OTHER

Dietary supplementation with Lactobacillus reuteri DSM 17938

Dietary Supplement: Lactobacillus reuteri DSM 17938

Interventions

Lactobacillus reuteri DSM 17938DIETARY_SUPPLEMENT

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

Lactobacillus reuteri

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes with a duration \> 6 months
  • Abdominal obesity
  • HbA1c 50-80 mmol/mol
  • Written informed consent
  • Stated availability throughout the study period

You may not qualify if:

  • Autoimmune diabetes eg type 1 diabetes
  • Psychiatric illness or cancer diagnosis
  • No foreseeable need of treatment with corticosteroids or antibiotics
  • Inflammatory bowel disease
  • Participation in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Gothenburg, S-413 45, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 17210919BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Per-Anders E jansson, Adj prof

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

    PRINCIPAL INVESTIGATOR

  • Fredrik Bäckhed, Assoc prof

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 15, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

SE(1)