Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
24/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Academic Medical Centre (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes