Clinical trial NCT00146289: The Primary Objective of This Study is to Determine Whether MICARDIS® Improves Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive Subjects
Official title: A Randomised, DB, Placebo-controlled, Parallel Group, 16-wk MICARDIS (160mg) Tab, Proof-of-concept, Evaluating Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive, Using the OGTT, With a Clamp Sub-group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Insulin Resistance
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine whether MICARDIS® improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects.


Eligibility criteria: Inclusion Criteria:

1. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
2. Subjects 18-65 years old.
3. Body Mass Index (BMI) \>= 28.
4. Sedentary life style defined as: Does not engage in vigorous activity for more than 30 minutes per day, more than two times per week.
5. Waist circumference \>= 40 inches (102 cm) in men and \>= 35 inches (89 cm) women.
6. HbA1C assessed \<= 6.5%.
7. Triglycerides \>= 150, and \<= 500 mg/dL.
8. Fasting Glucose \<= 126 mg/dL.
9. Blood pressure \>= 110/64 and \<= 140/90 mmHg.

Exclusion Criteria:

1. Currently taking any antihypertensive medications (e.g., thiazide or loop diuretics), diabetic medications, medications known to alter insulin sensitivity (e.g., statins), steroids, glucocorticoids, niacin, nicotinic acid, and anti-psychotic/depressant drugs (e.g., prozocin). Including over the counter (OTC) and herbal products, which are known to affect metabolic function.
2. Diagnosis of any of the following chronic diseases: hypertension, diabetes mellitus, renal insufficiency, congestive heart failure, hepatic insufficiency, biliary obstructive disorders, autoimmune disease, HIV, coronary artery disease, mental illness, and severe anemia.
3. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
4. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
5. Unstable angina or myocardial infarction or cardiac surgery within the past 3 months.
6. PCI (percutaneous coronary intervention) within the past 3 months.
7. Stroke within the past 6 months.
8. Bilateral renal artery stenosis or obstructive disorders, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
9. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

   * SGPT (ALT) or SGOT (AST) \> 2.5 times the upper limit of normal range, or
   * Serum creatinine \> 2.3 mg/dL (or \> 203 mol/L)
10. Pre-menopausal women (last menstruation \<=1 year prior to signing informed consent) who:

    * Have a positive urine pregnancy test (UPT) prior to randomisation (Visit 2 or Visit 2.1 for subject participating in the clamp procedure)
    * Are not surgically sterile, or
    * Are nursing, or pregnant, or
    * Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study and do not agree to periodic pregnancy testing during participation in the study. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable or injectable contraceptives and estrogen patch. No exceptions will be made.
11. Hematocrit \< 35%.
12. Primary aldosteronism.
13. Hereditary fructose intolerance.
14. History of drug or alcohol dependency within the previous 6 months.
15. Currently participating in a weight loss program.
16. Any investigational drug therapy within one month of randomisation or during the study.
17. Known hypersensitivity to any component of the study drug (telmisartan or placebo).
18. Any circumstances the Investigator feels participation in the study would hinder subject safety or completion of the study.

Primary outcomes:
measure: The primary endpoint is the change from baseline to the end of study (16 weeks) in the insulin sensitivity index as estimated by the composite index (R04-1184) calculated from a 3-hour oral glucose tolerance test (OGTT).
Secondary outcomes:
measure: From baseline: Glucose disposal rates; Insulin sensitivity (IS) index as Rd/I (clamp); IS index (OGTT- min model); Insulin secretion capacity; fasting insulin & gluc.; AUC gluc & insulin; ratio of AUC glucose ÷ by AUC insulin; lipids & inflam. markers.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Medicine- Divison of Endocrinology
state: California
city: San Diego
country: United States
facility: University of CA at SanDiego- Department of Endocrinology
state: California
city: Westlake Village
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Chicago
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Illinois
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Ohio
city: Nashville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Tennessee
city: Harker Heights
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Winnipeg
country: Canada
facility: University of Manitoba, Diabetes Research Group
state: Manitoba
city: London
country: Canada
facility: St. Joseph's Health Care London
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Riverside Campus
state: Ontario
city: Aarhus C
country: Denmark
facility: Århus Sygehus
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin
city: Künzing
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Unterschneidheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Perugia
country: Italy
facility: Policlinico Monteluce
city: Pisa
country: Italy
facility: Azienda Ospedale Università di Pisa
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: