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ID
Source
Brief title
Health condition
Type 2 diabetes, metformin, gutmicrobiota
Sponsors and support
PO Box 22660
1100 DD Amsterdam
Netherlands
PO Box 22660
1100 DD Amsterdam
Netherlands
Intervention
Outcome measures
Primary outcome
Changes in faecal flora after 15 weeks.
Secondary outcome
1. Glycemic control;
2. Biochemical parameters;
3. Inflammatory parameters;
4. Weight.
Background summary
Metformin 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.
Study objective
Hypothesis: 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.
Study design
1. Baseline;
2. 5wk;
3. 10wk;
4. 15wk.
Intervention
1. Arm 1- 15 weeks metformin;
2. Arm 2- 15 weeks insulin (lantus).
A. Vrieze
Academic Medical Center, room F4-256
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665983
a.vrieze@amc.uva.nl
A. Vrieze
Academic Medical Center, room F4-256
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665983
a.vrieze@amc.uva.nl
Inclusion criteria
1. Male obese subjects with an impaired fasting glucose or newly diagnosed diabetes;
2. 21-65 yr;
3. BMI <45 kg/m2.
Exclusion criteria
1. Renal failure;
2. Liver function problems;
3. (History of) alcoholism.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1674 |
| NTR-old | NTR1775 |
| Other | CCMO : 26948 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |