A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients
Information source: Third Military Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Obesity
Intervention: Telmisartan plus Metformin (Drug); Telmisartan (Drug); Candesartan (Drug); Candesartan plus Metformin (Drug); Amlodipine (Drug); Amlodipine plus Metformin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Third Military Medical University Official(s) and/or principal investigator(s): Zhiming Zhu, MD, PhD, Principal Investigator, Affiliation: The third hospital affiliated to the Third Military Medical University. China Zhiming Zhu, MD, PhD, Study Director, Affiliation: The third hospital affiliated to the Third Military Medical University. China
Summary
The epidemic of obesity is associated with a considerable rise in the incidence of the
metabolic syndrome, type 2 diabetes mellitus, and hypertension. Insulin resistance plays an
important role in the pathogenesis of obesity related hypertension. These patients are at
high risk to suffer from cardiovascular events. However, current guidelines for treatment of
hypertension do not provide specific recommendation for the pharmacotherapy of obese
hypertensive patients due to lack of prospective randomized intervention studies in
non-diabetic obese hypertensive patients.
Aside from their antihypertensive effects, angiotensin II receptor blockers (ARB) were shown
to improve insulin sensitivity. Furthermore, metformin is commonly used to treat the obese
type 2 diabetes mellitus. Metformin can also lower body weight and increase insulin
sensitivity. In a prospective, double-blind, double-dummy, randomized, parallel-group study,
we will evaluate the effects of ARB (telmisartan and candesartan) or amlodipine combination
with metformin on weight gain, visceral fat, and metabolic parameters in obese hypertensive
patients without diabetes mellitus compared with obese hypertensives on ARB or amlodipine
treatment alone. This study will help to develop future comprehensive treatment strategies
and guidelines for obesity related hypertension.
Clinical Details
Official title: Which is the Best Treatment for Non-diabetic Hypertension With Obesity: Telmisartan, Amlodipine or Candesartan, Alone or Plus MEtformin? (HOT-ACME 1)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Blood PressureMetabolic profiles, including lipid profile and blood glucose
Secondary outcome: Abdominal fat assessed by CTObesity parameters, including waist circumference (WC) and body mass index (BMI) Insulin resistance assessed by fasting serum insulin and HOMA-IR Incidents of side effects between groups
Eligibility
Minimum age: 30 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Grade 1 or 2 hypertension: 140mmHg≤SBP<180mmHg, and/or 90mmHg≤DBP<110mmHg
- Waist circumference higher than 90cm in men, 80cm in women
Exclusion Criteria:
- Diabetes
- Grade 3 hypertension: SBP≥180mmHg, or DBP≥110mmHg
- known allergy or hypersensitivity to trial drugs
- Myocardial infarction or cerebrovascular accident in the year preceding the trial
- Clinical Congestive Heart Failure
- History of hepatitis or cirrhosis
- History of kidney disease
Locations and Contacts
The third hospital affiliated to the Third Military Medical University, Chongqing 400042, China
Additional Information
Starting date: February 2008
Last updated: May 12, 2013
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