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The role of free fatty acids in the glucose-lowering effects of thiazolidinediones.

The role of free fatty acids in the glucose-lowering effects of thiazolidinediones.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25285
Enrollment
13
Registered
2005-12-18
Start date
2002-09-01
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

Patients with DM II.

Interventions

1. Treatment with pioglitazone 30 mg once a day or placebo
2. Infusion of a lipid emulsion on the third study day in the active treatment group.

Sponsors

Eli Lilly
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Obese patients with Diabetes Mellitus type II (DM II); 2. BMI > 25 kg/m2; 3. Treatment for DM II with oral medication only; 4. Moderatly regulated DM II.

Exclusion criteria

Exclusion criteria: 1. Use of insulin; 2. Use of fibrates; 3. Plasma creatinine > 150 umol/L; 4. Transaminases > 2x upper limit of reference value; 5. Impaired cardiac function or angina pectoris; 6. Familial lipid metabolism disorder; 7. Women in reproductive age; 8. Epilepsy; 9. Proliferative retinopathy.

Design outcomes

Primary

MeasureTime frame
Basal glucose production and plasma FFA peripheral insulin sensitivity insulin-mediated suppression of FFA (=insulin sensitivity of adipose tissue).

Secondary

MeasureTime frame
Changes in concentrations of ceramide and glycosphingolipids in skeletal muscle.

Contacts

Public ContactM.J.M. Serlie

Academic Medical Center (AMC), Department of Endocrinology and Metabolism (F5-169) P.O. Box 22660

m.j.serlie@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)