Contact information
Type
Scientific
Primary contact
Dr M.J.M. Serlie
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Received from local medical ethics committee
Study design
Randomised single blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Pioglitazone
Primary outcome measures
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 trial start date
01/09/2002
Overall trial end date
31/05/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
13
Participant 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
Recruitment start date
01/09/2002
Recruitment end date
31/05/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
Funders
Funder type
Other
Funder name
Fellowship award from the European Society of Parenteral and Enteral Nutrition
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Eli Lilly BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17062758
Publication citations
-
Results
Serlie MJ, Allick G, Groener JE, Ackermans MT, Heijligenberg R, Voermans BC, Aerts JM, Meijer AJ, Sauerwein HP, Chronic treatment with pioglitazone does not protect obese patients with diabetes mellitus type II from free fatty acid-induced insulin resistance., J. Clin. Endocrinol. Metab., 2007, 92, 1, 166-171, doi: 10.1210/jc.2006-1518.