Telmisartan and Renal Perfusion in Patients With Metabolic Syndrome

NCT00452192 | Completed Phase 3

• 1 other identifier: SFB 423-TP B5 Niere MRT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A major complication of diabetes mellitus is diabetic nephropathy. In previous studies the investigators could demonstrate that in patients with type 2 diabetes mellitus despite unaltered basal and stimulated nitric oxide (NO) - activity, the renal response to the antioxidant vitamin C was more pronounced compared to control subjects. These data suggest that oxidative stress is increased in the renal vasculature of diabetic patients. Furthermore, NO-activity in diabetic patients appears to be up regulated to compensate for increase in oxidative stress. This hypothesis is supported by the demonstration of increased endothelial nitric oxide synthase (eNOS) expression in kidney biopsies of diabetic patients. Angiotensin receptor blockers have been found to reduce oxidative stress in various vascular beds. Some drugs of this class, Telmisartan for example, also exhibit partial agonist properties to the PPARγ receptor and might be of great benefit for patients with diabetes mellitus or metabolic syndrome due to an additional improvement in insulin resistance. Despite its effect on oxidative stress angiotensin receptor blockers beneficially alter renal haemodynamics by reducing intraglomerular pressure and thus protect against glomerular injury. Recent advances in magnetic resonance imaging lead to the development of new techniques that allow a separate measurement of renal medullar and cortical perfusion. This magnetic resonance imaging technique might be a useful tool to detect alterations at an early level in the kidneys of patients at high risk for diabetic nephropathy. In the current study, the investigators want to evaluate the new magnetic resonance imaging technique by measuring medullar and cortical renal perfusion before and after pharmacological intervention with telmisartan in patients with metabolic syndrome.

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Change in RPF to L-NMMA at baseline and after telmisartan (MRI)

  30 min

Interventions

Telmisartan DRUG

telmisartan 80 mg daily over 2 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subject of 18 to 65 years of age
• Subjects with at least 3 of 5 criteria of the metabolic syndrome:
• Central (abdominal) obesity: waist circumference \>= 102 cm
• Hypertension: \>=135/\>=85 mmHg
• Hypertriglyceridemia: \>= 150 mg/dL
• Low HDL -cholesterol: \< 40 mg/dL
• Hyperglycemia: fasting glucose \>= 110 mg/dL and
• Subjects with a history of essential hypertension or newly diagnosed with essential hypertension with a BP reaching following criteria:
• MSSBP \>=135 mmHg and \< 180 mmHg and/or MSDBP \>= 85 mmHg and \< 110 mmHg
• Subjects who are eligible, able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them. Existence of written informed consent.
• Subjects with normal renal function (according to the MDRD IV eGFR \> 60 ml/min/1.73m\^2)

You may not qualify if:

• Subjects treated with an ACE or an ARB within 3 month of study entry who are unable or unwilling to undergo the 3 month washout period.
• Known secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis).
• Any of the following conditions: Atrial fibrillation, AV block II or higher, history of myocardial infarction, instable angina pectoris, pathologic ECG changes, heart failure NYHA III/IV
• Severe Depression
• History of epileptic seizures
• Proliferative Retinopathy
• MSSBP pressure \> 180 mmHg or MSDBP \> 110 mmHg
• Known Renal arterial stenoses (on one or both sides)
• Known or suspected contraindications or intolerance to or history of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (e.g., ARBs) as the study drug.
• Subjects who take drugs that are not approved/admitted in germany or subjects participating now or three month prior to this trial in other studies.
• Therapy with not allowed concomitant drugs.
• Current abuse or recent history of alcohol or other drug substance abuse (past 12 month).
• Subjects that in the eye of the investigation seem to be noncompliant and unwilling or not able to show up for control examinations. Subjects with a history of non-compliance to medical regimes or unwillingness to comply with the study protocol.
• Subjects whose body structure (e.g., weight, height, body circumference, etc.) exceeds the restrictions of the local site of MRI instrument.
• Use of pacemakers, ICD, defibrillators, or any device which interferes with an MRI. Subjects that have any metallic material anywhere in their body that might interfere with an MRI.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg

Erlangen, 91054, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Roland. E Schmieder, MD

  Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 27, 2007
• Study Start: November 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

DE (1)