Trial Comparing Metabolic Effects of Telmisartan and Amlodipine on Hypertensive Patients With Obesity and Diabetes (HOT-DM)

Third Military Medical University

Status and phase: Completed; Phase 4

Conditions: Hypertension; Diabetes; Obesity

Treatments: Drug: Temisartan; Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT00847262

HOT-2

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Telmisartan Group

Experimental group

Description:

Telmisartan intervention group

Treatment:

Drug: Temisartan

Amlodipine Group

Active Comparator group

Description:

Amlodipine intervention group

Treatment:

Drug: Amlodipine