A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients

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: Recruiting

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

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

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.

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

Primary outcome: 1. Blood Pressure 2. Metabolic profiles, including lipid profile and blood glucose

Secondary outcome: 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

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

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

The third hospital affiliated to the Third Military Medical University, Chongqing 400042, China; Recruiting
Hongbo He, MD, Phone: 86-023-6661-2158, Email: cqhehongbo@gmail.com
Hongbo He, MD, Sub-Investigator
Zhigang Zhao, MD, Sub-Investigator

The third hospital affiliated to the Third Military Medical University, Chongqing 400042, China; Recruiting
Zhiming Zhu, MD, PhD, Phone: 86-023-6870-5094, Email: zhuzm@yahoo.com
Hongbo He, MD, Sub-Investigator

Starting date: February 2008
Ending date: October 2009
Last updated: May 29, 2008