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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21550

Enrollment

Registered

2009-04-24

Start date

2009-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes, metformin, gutmicrobiota

Interventions

2. Arm 2- 15 weeks insulin (lantus).

1. Arm 1- 15 weeks metformin

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Renal failure; 2. Liver function problems; 3. (History of) alcoholism.

Design outcomes

Primary

Measure	Time frame
Changes in faecal flora after 15 weeks.	—

Secondary

Measure	Time frame
1. Glycemic control; 2. Biochemical parameters; 3. Inflammatory parameters; 4. Weight.	—

Contacts

Public ContactA. Vrieze

PO Box 22660

a.vrieze@amc.uva.nl+31 (0)20 5665983

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)