Effects of olanzapine standard oral tablets and orally disintegrating tablets on gut hormones, glucose metabolism and pituitary hormones
| ISRCTN | ISRCTN17632637 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17632637 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 05/11/2010
- 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
Not provided at time of registration
Contact information
Dr S Vidarsdottir
Scientific
Scientific
Department Endocrinology and Metabolism
Leiden University Medical Centre, C4-R
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 3082 |
|---|---|
| s.vidarsdottir@lumc.nl |
Study information
| Study design | Randomised, active controlled, crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | Novel antipsychotic drugs cause weight gain and type two diabetes mellitus in a large percentage of patients. The mechanism of the serious metabolic side effects of these drugs is unclear. Olanzapine orally disintegrating tablet has been found to cause less weight gain than olanzapine standard oral tablet. We hypothesised that these two different forms of olanzapine differ in their effect of gut peptide release to explain their dramatically distinct impact on body weight. To further uncover the mechanism through which olanzapine causes weight gain and diabetes mellitus we also studied the impact of olanzapine on spontaneous release of various hormones (i.e. cortisol, prolactin, leptin, adinponectin, insulin, glucose, Free Fatty Acids [FFA] and Triglycerides [TG]). |
| Ethics approval(s) | Approval received from the ethics board in the Leiden University Medical Center (LUMC)(Commissie Medische Ethiek LUMC) on the 28th February 2006 (ref: P06-005/YR/kdw). |
| Condition | Diabetes Mellitus type two (DM type II) |
| Intervention | Subjects are studied after intervention with olanzapine standard tablet (10 mg/day for eight days), olanzapine orally disintegrating tablet (10 mg/day for eight days) and without intervention (control). On day seven subjects were submitted in the clinical reasearch unit, antropometric measures, body composition and fuel oxidation were measured. Blood samples for glucose, insulin, FFA and TG were drawn every ten minutes, from 30 minutes before until two hours after dinner and breakfast. Blood samples for gut peptides were drawn every 20 to 30 minutes from one hour before until four hours after dinner and breakfast. Samples for determination of Adrenocorticotropic Hormone (ACTH), cortisol, Prolactin (PRL) (every ten minutes), leptin (every 20 minutes) and adiponectin (every 30 minutes) were drawn from 00:00 until 12:hh hours. Physical activity was recorded with actimeters for three days, during the different experimental conditions. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Olanzapine standard oral tablets and orally disintegrating tablets |
| Primary outcome measure | 1. Antrhopometric measurements: BMI, Waist:Hip Ratio (WHR), body composition 2. Indirect calorimetry: Resting energy expenditure, respiratory quotient, glucose and fat oxidation 3. Plasma concentrations: insulin, glucose, FFA, TG, Peptide YY3-36 (PYY), Pancreatic Polypeptide (PP), Glucagon-like peptide-1 (GLP-1), Glucagon-like peptide-2 (GLP-2), Oxyntomodulin (OXM), Cholecystokinin (CCK), Ghrelin, ACTH, cortisol, PRL, Adiponectin, Leptin All primary end points were measured on day seven and eight of the intervention. |
| Secondary outcome measures | Physical activity, this was measured for three days between day one and four of the intervention. |
| Overall study start date | 10/04/2006 |
| Overall study end date | 26/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 12 |
| Participant inclusion criteria | 1. Healthy men without a positive family history of schizophrenia 2. Age between 20 and 40 years 3. Fasting plasma glucose less than 6 mmol/L 4. Body Mass Index (BMI) between 20 and 26 kg/m^2 |
| Participant exclusion criteria | 1. Fasting plasma glucose greater than 6 mmol/L 2. BMI greater than 26 kg/m^2 3. Psychiatric disorder and/or use of antipsychotic or antidepressants drugs at present or in the past 4. Gastrointestinal operations in the past 5. Any significant chronic disease 6. Renal, hepatic or endocrine disease 7. Use of medication known to influence lipolysis and or glucose metabolism 8. Total cholesterol greater than 7 mmol/L and or triglycerides greater than 2 mmol/L 9. Recent weight changes or attempts to lose weight (greater than 3 kg weight gain or loss, within the last three months) 10. Difficulties to insert an intravenous catheter 11. Smoking (current) 12. Alcohol/drug abuse 13. Severe claustrophobia 14. Recent blood donation (within the last two months) 15. Recent participation in other research projects (within the last three months), participation in two or more projects in one year 16. Extensive sporting activities (more than ten hours of exercise per week) |
| Recruitment start date | 10/04/2006 |
| Recruitment end date | 26/09/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department Endocrinology and Metabolism
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Endocrinology and Metabolism
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 3082 |
|---|---|
| h.pijl@lumc.nl | |
| Website | http://www.lumc.nl/english/start_english.html |
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Industry
Eli Lilly (The Netherlands)
No information available
Dutch Diabetes Research Fund (The 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 | 01/09/2010 | Yes | No |
