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NCT Number: NCT01620125

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Gothenburg, S-413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus reuteri DSM 17938

Dietary Supplement

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

Primary outcomes

  1. HOMA index

    Time frame: 12 weeks

    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).

Secondary outcomes

  1. Changes in diabetes medication and hypoglycemia events

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 15, 2012
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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