Type 2 DiabetesNCT01836796
Metabolic Effects of Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes
A study testing Lactobacillus Reuteri and Lactobacillus Reuteri DSM17938 in people with Type 2 Diabetes, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Lactobacillus Reuteri and Lactobacillus Reuteri DSM17938
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSweden
- Study dates
- May 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Administration of antibiotics 4 weeks before inclusion
- Administration of probiotics 2 weeks before inclusion
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Clinical Trial Centre, Gröna Stråket 12, Sahlgrenska University Hospital
Gothenburg, S-413 45
About this study
Official title: Metabolic Effects of Dietary Supplementation With Lactobacillus Reuteri DSM 17938 - a Randomised Placebo Controlled Proof-of-concept Study in Type 2 Diabetes
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.
Read the detailed description
This is a double-blind, placebo controlled randomised study with three parallel groups of type 2 diabetes (T2D) patients receiving either placebo, Lactobacillus reuteri DSM 17938, 1 x 108 (colony-forming units) CFU or Lactobacillus reuteri DSM 17938 CFU 1 x 1010.
The study will be performed at the Clinical Trial Centre (CTC) at the Sahlgrenska University Hospital in Gothenburg. The investigators will recruit forty-five T2D patients of both gender 50-75 yrs, with waist circumference > 80 cm and > 94 cm in women and men, respectively, HbA1c 50-90 mmol/mol and treatment to achieve normoglycemia with lifestyle, insulin with or without oral hypoglycemic agents. Patients who meet all inclusion criteria will be asked to join the study and will be given full written information on the study before being asked to sign a written consent form.
Recruited patients will then undergo a baseline examination with collection of demographic data, fasting blood and urine samples and measurements of blood pressure.
After less than three weeks, the patients return for 1.5 days of investigations. At baseline, urine, blood and faeces samples are taken but also body composition assessed with (Dual Energy X-ray Absorbtion) DEXA, proton magnetic resonance spectroscopy to quantify liver fat content, magnetic resonance imaging (MRI) for determination of visceral adipose tissue and subcutaneous adipose tissue area at the level of L4-L5, a euglycemic hyperinsulinemic clamp at 120 milliunits (mU)/m2/min and finally in conjunction with the glucose clamp, indirect calorimetry, pulse wave analysis and abdominal subcutaneous needle biopsy.
At visit 3 the glucose clamp, day 0, patients will be randomized and given the study medication for the whole study period with instructions to take one dose per day (in the morning before breakfast). Patients then return at day 28 and day 56 for urine, faeces and blood sampling. After 12 weeks supplementation on day 84±7 days, blood, urine and faeces samples and all procedures performed at baseline in conjunction with day 0 are repeated. Moreover, patients return study medications not being used. Finally, patients who completed the study and will be asked to book a visit to their ordinary diabetes team.
- Conditions
- Type 2 Diabetes
- Being tested
- Lactobacillus Reuteri, Lactobacillus Reuteri DSM17938
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus ReuteriDietary supplement
100 million Lactobacillus Reuteri once daily or 10 billion Lactobacillus Reuteri once daily for 12 weeks.
Lactobacillus Reuteri DSM17938Dietary supplement
Powder corresponding to 100 million or 10 billion Lactobacillus Reuteri is added to water once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus Reuteri low | Active comparator | 100 million Lactobacillus Reuteri once daily Receives: Dietary Supplement: Lactobacillus Reuteri; Dietary Supplement: Lactobacillus Reuteri DSM17938 |
| Lactobacillus Reuteri High | Active comparator | 10 billion Lactobacillus Reuteri once daily Receives: Dietary Supplement: Lactobacillus Reuteri; Dietary Supplement: Lactobacillus Reuteri DSM17938 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Lactobacillus Reuteri DSM17938 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 12 weeks compared to baseline
Secondary outcomes (3)
Liver steatosis
Measured: Baseline compared to 12 weeks
Insulin sensitivity in muscle, liver and adipose tissue
Measured: Baseline compared to 12 weeks
Urine albumine excretion rate
Measured: Baseline compared to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startMay 2012
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- BioGaia AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836796
- Sponsor's protocol ID
- CSUB0056
- Status last verified
- Oct 2013
- First submitted
- 17 Apr 2013
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Dietary Supplementation With Lactobacillus Reuteri DSM 17938 - a Randomised Placebo Controlled Proof-of-concept Study in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01836796
- Acronym / sponsor ID
- CSUB0056
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- BioGaia AB
- Study start
- May 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a double-blind, placebo controlled randomised study with three parallel groups of type 2 diabetes (T2D) patients receiving either placebo, Lactobacillus reuteri DSM 17938, 1 x 108 (colony-forming units) CFU or Lactobacillus reuteri DSM 17938 CFU 1 x 1010.
The study will be performed at the Clinical Trial Centre (CTC) at the Sahlgrenska University Hospital in Gothenburg. The investigators will recruit forty-five T2D patients of both gender 50-75 yrs, with waist circumference > 80 cm and > 94 cm in women and men, respectively, HbA1c 50-90 mmol/mol and treatment to achieve normoglycemia with lifestyle, insulin with or without oral hypoglycemic agents. Patients who meet all inclusion criteria will be asked to join the study and will be given full written information on the study before being asked to sign a written consent form.
Recruited patients will then undergo a baseline examination with collection of demographic data, fasting blood and urine samples and measurements of blood pressure.
After less than three weeks, the patients return for 1.5 days of investigations. At baseline, urine, blood and faeces samples are taken but also body composition assessed with (Dual Energy X-ray Absorbtion) DEXA, proton magnetic resonance spectroscopy to quantify liver fat content, magnetic resonance imaging (MRI) for determination of visceral adipose tissue and subcutaneous adipose tissue area at the level of L4-L5, a euglycemic hyperinsulinemic clamp at 120 milliunits (mU)/m2/min and finally in conjunction with the glucose clamp, indirect calorimetry, pulse wave analysis and abdominal subcutaneous needle biopsy.
At visit 3 the glucose clamp, day 0, patients will be randomized and given the study medication for the whole study period with instructions to take one dose per day (in the morning before breakfast). Patients then return at day 28 and day 56 for urine, faeces and blood sampling. After 12 weeks supplementation on day 84±7 days, blood, urine and faeces samples and all procedures performed at baseline in conjunction with day 0 are repeated. Moreover, patients return study medications not being used. Finally, patients who completed the study and will be asked to book a visit to their ordinary diabetes team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus Reuteri low | Active comparator | Dietary Supplement: Lactobacillus Reuteri, Dietary Supplement: Lactobacillus Reuteri DSM17938100 million Lactobacillus Reuteri once daily |
| Lactobacillus Reuteri High | Active comparator | Dietary Supplement: Lactobacillus Reuteri, Dietary Supplement: Lactobacillus Reuteri DSM1793810 billion Lactobacillus Reuteri once daily |
| Placebo | Placebo comparator | Dietary Supplement: Lactobacillus Reuteri DSM17938 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus Reuteri100 million Lactobacillus Reuteri once daily or 10 billion Lactobacillus Reuteri once daily for 12 weeks. | Dietary supplement | Lactobacillus Reuteri High, Lactobacillus Reuteri low |
| Lactobacillus Reuteri DSM17938Powder corresponding to 100 million or 10 billion Lactobacillus Reuteri is added to water once daily for 12 weeks. | Dietary supplement | Lactobacillus Reuteri High, Lactobacillus Reuteri low, Placebo |
Primary outcome
HbA1c
Time frame: 12 weeks compared to baseline
3 secondary outcomes
Liver steatosis
Time frame: Baseline compared to 12 weeks
Insulin sensitivity in muscle, liver and adipose tissue
Time frame: Baseline compared to 12 weeks
Urine albumine excretion rate
Time frame: Baseline compared to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus Reuteri and Lactobacillus Reuteri DSM17938 in people with Type 2 Diabetes, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 12 weeks compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013.