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Trial Comparing Metabolic Effects of Telmisartan and Amlodipine on Hypertensive Patients With Obesity and Diabetes

NCT ID: NCT00847262

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-06-30

Brief Summary

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Recent studies have shown that obese people are more prone to high blood pressure. With the co-existence of obesity, hypertension and diabetes, patients were more susceptible to hyperlipidemia, coronary and cerebral atherosclerosis and peripheral vascular disease. Abdominal obesity has often accompanied by substantial accumulation of visceral fat, which increased secretion of many inflammatory mediators, cytokines and adipocytokines and played an important role in cardiovascular and metabolic disease. Some reports had shown that angiotensin II receptor blockers (ARB) may improve metabolic profiles in patients with diabetes or metabolic syndrome, in addition to its hypotensive effect. It has been reported that some ARB, such as telmisartan and candesartan, can prevent weight gain and high-fat-induced obesity in experimental animals. However, whether telmisartan intervention on improvement of fat deposition and other related metabolic profiles is better than a CCB drugs (amlodipine) in those obese hypertensive patients with diabetes, was still unknown.

Detailed Description

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Conditions

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Hypertension Obesity Diabetes

Keywords

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Hypertension Abdominal obesity Diabetes Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telmisartan Group

Telmisartan intervention group

Group Type EXPERIMENTAL

Temisartan

Intervention Type DRUG

Temisartan, initial dose: 40 mg per day, Max dose: 160 mg per day

Amlodipine Group

Amlodipine intervention group

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

Amlodipine, initial dose: 5 mg per day, Max dose: 10 mg per day

Interventions

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Temisartan

Temisartan, initial dose: 40 mg per day, Max dose: 160 mg per day

Intervention Type DRUG

Amlodipine

Amlodipine, initial dose: 5 mg per day, Max dose: 10 mg per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Information Consent Signed
* Aged 30\~70 years
* For whom without anti-hypertensive therapy in 2 weeks：140mmHg≤SBP\<180mmHg，或90mmHg≤DBP\<110mmHg. For whom with anti-hypertensive therapies in 2 weeks：SBP\<180mmHg, 且DBP\<110mmHg
* Waist circumference higher than 90cm in men, 80cm in women
* Diagnosed diabetes

Exclusion Criteria

* Grade 3 hypertension: SBP≥180mmHg, or DBP≥110mmHg
* Waist circumference less than 90cm in men, 80cm in women
* Known allergy or hypersensitivity to trial drugs
* NYHA grade Ⅱ\~Ⅳ heart failure, Myocardial infarction or cerebrovascular accident in 1 year preceding the trial
* Acute infections, tumor, severe arrhythmia, mental disease, drug or alcohol abuse
* History of hepatitis or cirrhosis
* History of severe kidney disease
* Pregnant, lactation
* Enrolled in other trials in 3 months
* Any obstacles of follow-up or compliance
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhiming Zhu

Chief of the Department of Hypertension & Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiming Zhu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The third hospital affiliated to the Third Military Medical University. China

Locations

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The third hospital affiliated to the Third Military Medical University

Chongqing, , China

Site Status

Countries

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China

Other Identifiers

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HOT-2

Identifier Type: -

Identifier Source: org_study_id