Effects of Olanzapine standard oral tablets and orally disintegrating tablets on gut hormones, glucose metabolism and pituitary hormones.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR936
• Date of registration: 15/03/2007
• Primary sponsor: Leiden University Medical Center (LUMC), Department Endocrinology and Metabolism
• Public title: Effects of Olanzapine standard oral tablets and orally disintegrating tablets on gut hormones, glucose metabolism and pituitary hormones.
• Scientific title: Effects of Olanzapine standard oral tablets and orally disintegrating tablets on gut hormones, glucose metabolism and pituitary hormones. - N/A
• Date of first enrolment: 10/4/2006
• Target sample size: 12
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=936
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Crossover; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: H. Pijl

• Name: S. Vidarsdottir

Key inclusion & exclusion criteria

Inclusion criteria: 1. Healthy men without a positive family history of schizophrenia;

2. Age between 20 and 40 yr.

3. Fasting plasma glucose < 6 mmol/L.

4. BMI between 20 and 26 kg/m2.
Exclusion criteria: 1. Fasting plasma glucose > 6 mmol/L.

2. BMI > 26 kg/m2.

3. Psychiatric disorder and/or use of antipsycotic 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 > 7 mmol/L and or triglycerides > 2 mmol/L.

9. Recent weight changes or attempts to loose weight (>3 kg weight gain or loss, within the last 3 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 2 months).

15. Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year.

16. Extensive sporting activities (more than 10 hours of exercise per week).

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Diabetes Mellitus type 2 (DM type II), Insulin resistance, Antipsychotics

Intervention(s)

Subjects are studied after intervention with olanzapine standard tablet (10mg/day for 8 days), Olanzapine orally disintegrating tablet (10 mg/day for 8 days) and without intervention (control). On day 7 subjects were submitted in the clinical reasearch unit, antropometric measures, body composition and fuel oxidation were measured. Blood samples for glucose, insulin, FFA en TG were drawn every 10 minutes, from 30 min before until 2 hours after dinner and breakfast. Blood samples for gut peptides were drawn every 20-30 minutes from 1 hour before until 4 hours after dinner and breakfast. Samples for determination of ACTH, cortisol, PRL (every 10 min), leptin (every 20 min) and adiponectin (every 30 min) were drawn from 00:00 until 12:hh h. Physical activity was recorded with actimeters for 3 days, during the different experimental conditions.

Primary Outcome(s)

1. Antrhopometric measurements: BMI, WHR, Body composition.

2. Indirect calorimetry: Resting energy expenditure, respiratory quotient, glucose and fat oxidation.

3. Plasma concentrations: Insulin, glucose, FFA, TG, PYY, PP, GLP-1, GLP-2, OXM, CCK, Ghrelin, ACTH, cortisol, PRL, Adiponectin, Leptin.

Secondary Outcome(s)

Physical activity.

Secondary ID(s)

ISRCTN17632637

Source(s) of Monetary Support

Diabetes Research Fund , Eli Lilly Nederland B.V.