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

ISRCTN	ISRCTN47118569
DOI	https://doi.org/10.1186/ISRCTN47118569
Secondary identifying numbers	N/A

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

Academic Medical Center
Department of Department of Endocrinology and Metabolism (F5-169)
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Email	m.j.serlie@amc.uva.nl

Study information

Study design	Randomised single blind placebo controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Pioglitazone
Primary outcome measure	1. Basal glucose production and plasma FFA 2. Peripheral insulin sensitivity 3. Insulin-mediated suppression of FFA (= insulin sensitivity of adipose tissue)
Secondary outcome measures	Changes in concentrations of ceramide and glycosphingolipids in skeletal muscle.
Overall study start date	01/09/2002
Completion date	31/05/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Sponsor information

Academic Medical Centre (Netherlands)
Hospital/treatment centre

Department of Endocrinology and Metabolism
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Other

Fellowship award from the European Society of Parenteral and Enteral Nutrition

No information available

Eli Lilly BV (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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