The effects of heme arginate treatment on insulin resistance and vascular dysfunction related to obesity.

In vivo induction of heme oxygenase-1 (HO-1) in the metabolic syndrome.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29539

Enrollment

Registered

2010-08-11

Start date

2010-08-26

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

Metabolic syndrome, insulin resistance and endothelial dysfunction.

Interventions

Two treatment periods in a randomized order: 1. During one treatment period subjects will be treated intravenously with heme arginate (Normosang) 3 mg/kg on day 1 and 3

2. During the other treatment period subjects will be treated intravenously with L-arginine 3,2 mg/kg on day 1 and 3. Wash out period of 2 months in between.

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 - 70 years of age; 2. Both men and women; 3. Metabolic syndrome as defined by the presence of at least 3 out of 5 characteristics: A. Elevated waist circumference; B. Elevated triglycerides; C. Reduced HDL cholesterol; D. Elevated blood pressure; E. Elevated fasting glucose.

Exclusion criteria

Exclusion criteria: 1. History of smoking within the past year; 2. Known diabetes; 3. History or signs of cardiovascular disease; 4. Use of antihypertensive, cardiac or other vasoactive medication.

Design outcomes

Primary

Measure	Time frame
Insulin sensitivity.	—

Secondary

Measure	Time frame
1. Endothelial function; 2. Anti-oxidant capacity of plasma.	—

Contacts

Public ContactDouwe Dekker

PO box 9101

d.dekker@aig.umcn.nl+31 (0)24 3616723

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)