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AFFIRM trial:Alterations in Faecal Flora Intrinsically Related to Metformin.


- candidate number5650
- NTR NumberNTR1775
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-apr-2009
- Secondary IDs26948 CCMO
- Public TitleAFFIRM trial:Alterations in Faecal Flora Intrinsically Related to Metformin.
- Scientific TitleAFFIRM trial: Alterations in Faecal Flora Intrinsically Related to Metformin.
- ACRONYMAFFIRM trial
- hypothesisHypothesis: the working mechanims of metformin can be partly explained by its effect on the composition of the gut microbiota, with changes in inretin secretion and inflammatory pathways as secondary effects.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Male obese subjects with an impaired fasting glucose or newly diagnosed diabetes;
2. 21-65 yr;
3. BMI <45 kg/m2.
- Exclusion criteria1. Renal failure;
2. Liver function problems;
3. (History of) alcoholism.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2009
- planned closingdate1-jun-2011
- Target number of participants18
- Interventions1. Arm 1- 15 weeks metformin;
2. Arm 2- 15 weeks insulin (lantus).
- Primary outcomeChanges in faecal flora after 15 weeks.
- Secondary outcome1. Glycemic control;
2. Biochemical parameters;
3. Inflammatory parameters;
4. Weight.
- Timepoints1. Baseline;
2. 5wk;
3. 10wk;
4. 15wk.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A. Vrieze
- CONTACT for SCIENTIFIC QUERIESDrs. A. Vrieze
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryMetformin is the first line treatment in newly diagnosed patients with diabetes type 2. Metformin is an effective anti-hyperglycemic agent, although its precise mechanism of action is still unknown. In our study we will try to confirm the hypothesis that the working mechanism of metformin can be partly explained by its effect on the gut microbiota by studying both bacterial changes and these pathways simultaneously. Thus, the improved insulin sensitivity with metformin use can probably be explained by the influence of metformin on the composition of the gut microbiota, with changes in incretin secretion and inflammation pathways as secondary effectors.
- Main changes (audit trail)
- RECORD24-apr-2009 - 23-sep-2009


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