An interventional study of Lactobacillus Reuteri and Lactobacillus Reuteri DSM17938 in Type 2 Diabetes, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-10-25.
Sponsored by Vastra Gotaland Region · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 46 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Vastra Gotaland Region is the lead sponsor of 267 studies on the registry; 107 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
100 million Lactobacillus Reuteri once daily
Dietary Supplement: Lactobacillus Reuteri · Dietary Supplement: Lactobacillus Reuteri DSM17938
10 billion Lactobacillus Reuteri once daily
Dietary Supplement: Lactobacillus Reuteri · Dietary Supplement: Lactobacillus Reuteri DSM17938
Dietary Supplement: Lactobacillus Reuteri DSM17938
100 million Lactobacillus Reuteri once daily or 10 billion Lactobacillus Reuteri once daily for 12 weeks.
Powder corresponding to 100 million or 10 billion Lactobacillus Reuteri is added to water once daily for 12 weeks.
HbA1c
Time frame: 12 weeks compared to baseline
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
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vastra Gotaland Region