Fatty Acid Induced Oxidative Stress: its role in preventing hypoglycemia
| ISRCTN | ISRCTN85121743 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85121743 |
| Protocol serial number | NTR517 |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funder | Academic Medical Centre (AMC) (Netherlands), Department of Endocrinology and Metabolism |
- Submission date
- 09/01/2006
- Registration date
- 09/01/2006
- Last edited
- 01/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M.R. Soeters
Scientific
Scientific
Academic Medical Center
Dept of Endocrinology & Metabolism
F5-162
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 7672/9111 |
|---|---|
| M.R.Soeters@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised open label placebo controlled crossover group trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study acronym | FIOS: Fatty acid Induced Oxidative Stress |
| Study objectives | Elevated levels of Free Fatty Acids during fasting induce oxidative stress and cause insulin resistance to maintain euglycemia. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | No condition, healthy person |
| Intervention | Subjects will undergo a period of fasting and are assigned to receive either acipimox (inhibitor lipilysis) 250 mg 4dd or placebo. Hereafter insulin sensitivity will be measured using stable isotope technique. Furthermore regulating hormones and lipids will be measured. Muscle specimens (v. lateralis) will be obtained for determination of intramyocellular lipids and transcription factors. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | acipimox |
| Primary outcome measure(s) |
Insulin resistance, Free fatty acids and oxidative stress with and without acipimox. |
| Key secondary outcome measure(s) |
Other measures of glucosehomeostasis: glucoregulatory hormones, (adipo)cytokines. |
| Completion date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 38 Years |
| Sex | Male |
| Target sample size at registration | 6 |
| Key inclusion criteria | 1. 6 healthy men 2. 18-38 years 3. Body mass index (BMI) 20-25 4. Stable weight during the last 3 months |
| Key exclusion criteria | 1. Diabetes 2. Diabetes first degree relatives 3. Hypercholesterolemia 4. High intensity sport activities 5. Positive oral glucose tolerance testing |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/03/2006 |
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 |
