Official Title: “Which is the Best Treatment for Non-Diabetic Hypertension With Obesity: Telmisartan, Amlodipine or Candesartan, Alone or Plus MEtformin? (HOT-ACME 1)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: Telmisartan plus Metformin
  • Telmisartan 80mg 1/d, Metformin 250mg 2/d
• Drug: Telmisartan
  • Telmisartan 80mg 1/d
• Drug: Candesartan
  • Candesartan 8mg daily
• Drug: Candesartan plus Metformin
  • Candesartan 8mg 1/d Metformin 250mg 2/d
• Drug: Amlodipine
  • Amlodipine 5mg 1/d
• Drug: Amlodipine plus Metformin
  • Amlodipine 5mg 1/d, Metformin 250mg 2/d

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group T
  • Telmisartan
• Experimental: Group T+M
  • Telmisartan plus Metformin
• Experimental: Group C
  • Candesartan
• Experimental: Group C+M
  • Candesartan pus Metformin
• Active Comparator: Group A
  • Amlodipine
• Experimental: Group A+M
  • Amlodipine plus Metformin

Primary Measures

• 1. Blood Pressure 2. Metabolic profiles, including lipid profile and blood glucose
  • Time Frame: Baseline, 24 weeks(End of trial)
    Safety Issue?: No

Secondary Measures

• 1. Abdominal fat assessed by CT 2. Obesity parameters, including waist circumference (WC) and body mass index (BMI) 3. Insulin resistance assessed by fasting serum insulin and HOMA-IR 4. Incidents of side effects between groups
  • Time Frame: Baseline, 24 weeks(End of trial)
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Third Military Medical University

Overall Clinical Trial Officials and Contacts

Zhiming Zhu, MD, PhD Principal Investigator The third hospital affiliated to the Third Military Medical University. China  

Overall Contact: Zhiming Zhu, MD, PhD 86-023-6870-5094 zhuzm@yahoo.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00538486

Study ID Number: HOT-ACME 1

ClinicalTrials.gov Identifier: NCT00538486

Health Authority: China: Ministry of Health