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

Study Overview
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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.

Official Title
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Hypertension With Obesity Trial: Diabetes Mellitus Branch

Conditions
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Hypertension, Obesity, Diabetes

Intervention / Treatment
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* Drug: Temisartan
* Drug: Amlodipine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan Group<br>Telmisartan intervention group | Drug: Temisartan<br>* Temisartan, initial dose: 40 mg per day, Max dose: 160 mg per day<br>|
| Active Comparator: Amlodipine Group<br>Amlodipine intervention group | Drug: Amlodipine<br>* Amlodipine, initial dose: 5 mg per day, Max dose: 10 mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Incidents of side effects between groups |  | Baseline, 24 weeks(End of trial) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Abdominal obesity, Diabetes, Treatment