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

Phase 4

Completed

• Conditions: Hypertension; Obesity
• Interventions: Drug: Amlodipine plus Metformin; Drug: Telmisartan plus Metformin; Drug: Candesartan plus Metformin; Drug: Candesartan; Drug: Amlodipine; Drug: Telmisartan

• Registration Number: NCT00538486
• Lead Sponsor: Third Military Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-01
• Study First Submitted QC: 2007-10-01
• Study First Posted: 2007-10-02
• Study Start: 2008-02
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-12
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A+M	Amlodipine plus Metformin	Amlodipine plus Metformin
Group T+M	Telmisartan plus Metformin	Telmisartan plus Metformin
Group C+M	Candesartan plus Metformin	Candesartan pus Metformin
Group C	Candesartan	Candesartan
Group A	Amlodipine	Amlodipine
Group T	Telmisartan	Telmisartan

Primary Outcome Measures

Name	Time	Method
Blood Pressure	Baseline, 24 weeks(End of trial)
Metabolic profiles, including lipid profile and blood glucose	Baseline, 24 weeks(End of trial)

Secondary Outcome Measures

Name	Time	Method
Abdominal fat assessed by CT	Baseline, 24 weeks(End of trial)
Obesity parameters, including waist circumference (WC) and body mass index (BMI)	Baseline, 24 weeks(End of trial)
Insulin resistance assessed by fasting serum insulin and HOMA-IR	Baseline, 24 weeks(End of trial)
Incidents of side effects between groups	Baseline, 24 weeks(End of trial)

Trial Locations

Locations (1)

The third hospital affiliated to the Third Military Medical University; 🇨🇳 Chongqing, China