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

Third Military Medical University

Status and phase: Completed; Phase 4

Conditions: Hypertension; Obesity

Treatments: Drug: Amlodipine plus Metformin; Drug: Telmisartan plus Metformin; Drug: Amlodipine; Drug: Candesartan plus Metformin; Drug: Telmisartan; Drug: Candesartan

Study type: Interventional

Funder types: Other

Identifiers

NCT00538486

HOT-ACME 1

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 6 patient groups

Group T

Experimental group

Description:

Telmisartan

Treatment:

Drug: Telmisartan

Group T+M

Experimental group

Description:

Telmisartan plus Metformin

Treatment:

Drug: Telmisartan plus Metformin

Group C

Experimental group

Description:

Candesartan

Treatment:

Drug: Candesartan

Group C+M

Experimental group

Description:

Candesartan pus Metformin

Treatment:

Drug: Candesartan plus Metformin

Group A

Active Comparator group

Description:

Amlodipine

Treatment:

Drug: Amlodipine

Group A+M

Experimental group

Description:

Amlodipine plus Metformin

Treatment:

Drug: Amlodipine plus Metformin