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Completed

NCT Number: NCT00847262

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

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.

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Key information

Conditions

Hypertension Body Weight Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The third hospital affiliated to the Third Military Medical University

Chongqing, 400042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temisartan

Drug

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

Amlodipine

Drug

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

Primary outcomes

  1. Blood Pressure

    Time frame: Baseline, 24 weeks(End of trial)

  2. Metabolic profiles, including lipid profile and blood glucose

    Time frame: Baseline, 24 weeks(End of trial)

Secondary outcomes

  1. Abdominal fat assessed by CT

    Time frame: Baseline, 24 weeks(End of trial)

  2. Obesity parameters, including waist circumference (WC) and body mass index (BMI)

    Time frame: Baseline, 24 weeks(End of trial)

  3. Incidents of side effects between groups

    Time frame: Baseline, 24 weeks(End of trial)

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

Hypertension With Obesity Trial: Diabetes Mellitus Branch

Acronym: HOT-DM

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Feb 19, 2009
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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