The role of free fatty acids in the glucose-lowering effects of thiazolidinediones
| ISRCTN | ISRCTN47118569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47118569 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Centre (Netherlands) |
| Funders | Fellowship award from the European Society of Parenteral and Enteral Nutrition, Eli Lilly BV (Netherlands) |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 24/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M.J.M. Serlie
Scientific
Scientific
Academic Medical Center
Department of Department of Endocrinology and Metabolism (F5-169)
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| m.j.serlie@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Thiazolidinediones (TZDs, Pioglitazone) lower free fatty acids (FFA) in plasma via increased insulin sensitivity (= decreased lipolysis) in adipose tissue. The decrease in plasma FFA results in increased insulin sensitivity in skeletal muscle. Increasing plasma FFA to baseline levels while on TZD treatment will decrease peripheral insulin sensitivity to pre-treatment levels indicating that the mechanism of action of Pioglitazone is not directly on muscle but via lowering of plasma FFA due to the beneficial effects on adipose tissue. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Diabetes Mellitus type II (DM type II) |
| Intervention | Treatment with pioglitazone 30 mg once a day or placebo. Infusion of a lipid emulsion on the third study day in the active treatment group. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pioglitazone |
| Primary outcome measure(s) |
1. Basal glucose production and plasma FFA |
| Key secondary outcome measure(s) |
Changes in concentrations of ceramide and glycosphingolipids in skeletal muscle. |
| Completion date | 31/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 13 |
| Key inclusion criteria | 1. Obese patients with Diabetes Mellitus type II (DM II) 2. Body mass index (BMI) >25 kg/m2 3. Treatment for DM II with oral medication only 4. Moderately regulated DM II |
| Key exclusion criteria | 1. Use of insulin 2. Use of fibrates 3. Plasma creatinine >150 umol/l 4. Transaminases >2 x upper limit of reference value 5. Impaired cardiac function or angina pectoris 6. Familial lipid metabolism disorder 7. Premenopausal women 8. Epilepsy 9. Proliferative retinopathy |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 31/05/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2007 | Yes | No |
