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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29380

Enrollment

Registered

2007-03-15

Start date

2006-04-10

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

engels: antipsychotic drugs, type 2 diabetes mellitus, insulin resistance Nederlands: antipsychoticum, diabetes mellitus type 2, insuline resistentie

Interventions

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

Eligibility

Inclusion 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

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Physical activity.	—

Contacts

Public ContactS. Vidarsdottir

Department Endocrinology and Metabolism, Leiden University Medical Center, C4-R, P.O. Box 9600

s.vidarsdottir@lumc.nl31 71 5263082

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)