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

Phase 4

Completed

• Conditions: Obesity; Hypertension; Diabetes
• Interventions: Drug: Temisartan; Drug: Amlodipine

• Registration Number: NCT00847262
• Lead Sponsor: Third Military Medical University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-12
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Study Completion: 2009-06
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-15
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmisartan Group	Temisartan	Telmisartan intervention group
Amlodipine Group	Amlodipine	Amlodipine intervention group

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)
Incidents of side effects between groups	Baseline, 24 weeks(End of trial)
Obesity parameters, including waist circumference (WC) and body mass index (BMI)	Baseline, 24 weeks(End of trial)

Trial Locations

Locations (1)

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