Metabolic Control Before and After Supplementation With Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes Patients
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|ClinicalTrials.gov Identifier: NCT01620125|
Recruitment Status : Unknown
Verified June 2012 by Vastra Gotaland Region.
Recruitment status was: Recruiting
First Posted : June 15, 2012
Last Update Posted : June 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Insulin Resistance||Dietary Supplement: Lactobacillus reuteri DSM 17938||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabolic Control of Type 2 Diabetes Patients Before and After Dietary Supplementation With the Probiotic Lactobacillus Reuteri DSM 17938 - a Pilot Study|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Dietary supplementation with Lactobacillus reuteri DSM 17938
Dietary Supplement: Lactobacillus reuteri DSM 17938
Ordinary treatment against type 2 diabetes is supplemented with one tablet containing 100 million Lactobacillus reuteri DSM 17398, once daily for 12 weeks
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620125
|Contact: Per-Anders E Jansson, Adj prof||46 31 342 10 00 ext 73 email@example.com|
|Gothia Forum, CTC, Gröna Stråket 12, Sahlgrenska University Hospital||Recruiting|
|Gothenburg, Sweden, S-413 45|
|Contact: Kaj Stenlöf, Director 46 708 76 01 30 firstname.lastname@example.org|
|Sub-Investigator: Niklas Rydberg, MD|
|Principal Investigator:||Per-Anders E jansson, Adj prof||The Wallenberg Laboratory, Bruna Stråket 16, Sahlgrenska University Hospital S-413 45 Gothenburg, Sweden|
|Study Chair:||Fredrik Bäckhed, Assoc prof||The Wallenberg Laboratory, Bruna Stråket 16, Sahlgrenska University Hospital, S-413 45 Gothenburg, Sweden|