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Completed

NCT Number: NCT01160991

Effect of Atypical Antipsychotic Drugs Olanzapine and Amisulpride on Glucose Metabolism

Patients suffering from schizophrenia have a high risk to become obese and develop diabetes. Risk of obesity is particularly high with some newer schizophrenia drugs, such as clozapine or olanzapine. These drugs are called atypical drugs and exert their action in part by occupying receptors for serotonin, particularly the 5HT2A receptor subtype. This receptor may also interfere with glucose metabolism and insulin action. The purpose of this study is to compare an atypical antipsychotic drugs, olanzapine, which acts by occupying the 5HT2A receptor, to another antipsychotic drug, amisulpride, which mainly acts through the dopamine pathway. Healthy volunteers are recruited and asked to take a single dose of each drug and of placebo on separate days. Then, a combined glucose clamp study will be performed in order to test the effects of these drugs on insulin sensitivity and insulin secretion.

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Key information

Conditions

Schizophrenia Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Central Institute of Mental Health

Mannheim, 68159, Germany

About this study

10 male healthy volunteers are recruited. After informed consent, they are admitted to the study ward at 10:00 p.m. prior to the study day and kept fasting until the next morning. At 8:00 a.m. they receive their study medication (olanzapine, amisulpride or placebo). Subsequently, measurements of insulin sensitivity and insulin secretion are performed by euglycemic hyperinsulinemic clamp technique followed by hyperglycemic clamp.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy male volunteers
  • written informed consent

Exclusion criteria

  • BMI > 30 kg/m²
  • Diabetes mellitus
  • Hypertension
  • Treatment with drugs interfering with lipid or glucose metabolism (e.g. statins, oral antidiabetic drugs, glucocorticoids)
  • History of seizures

Treatment and study plan

Glucose clamp technique

Procedure

euglycemic hyperinsulinemic clamp with target blood glucose of 90 mg/dl (5 mmol/l), followed by hyperglycemic clamp, target blood glucose of 180 mg/dl (10 mmol/l) for measurement of insulin sensitivity and insulin secretion

Amisulpride

Drug

Single dose of amisulpride 200 mg p.o. given at 8:00 a.m.

Olanzapine

Drug

Single dose of olanzapine 10 mg p.o. given at 8:00 a.m.

Placebo

Drug

Placebo capsules are given at 8:00 a.m.

Primary outcomes

  1. insulin sensitivity

    Time frame: 90 thru 120 min after application of study drug

    m-value during euglycemic glucose clamp (glucose infusion rate divided by time and body weight)

Secondary outcomes

  1. pancratic c-peptide secretion

    Time frame: 120 thru 180 minutes after administration of study drug

    C-peptide measured 4 times during hyperglycemic clamp period at time 0 min (prior to glucose bolus), 5 min, 10 min and 60 min after glucose bolus

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Collaborators

  • Sanofi

Registry information

Official study title

Effects of the Serotonin 2A Receptor on Insulin Sensitivity and Secretion: a Double-blind Controlled Comparison of Olanzapine vs. Amisulpride:

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jul 13, 2010
Registry last updated
Aug 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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