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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00847262
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : December 17, 2013
Information provided by (Responsible Party):
Zhiming Zhu, 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.

Condition or disease Intervention/treatment Phase
Hypertension Obesity Diabetes Drug: Temisartan Drug: Amlodipine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypertension With Obesity Trial: Diabetes Mellitus Branch
Study Start Date : June 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telmisartan Group
Telmisartan intervention group
Drug: Temisartan
Temisartan, initial dose: 40 mg per day, Max dose: 160 mg per day

Active Comparator: Amlodipine Group
Amlodipine intervention group
Drug: Amlodipine
Amlodipine, initial dose: 5 mg per day, Max dose: 10 mg per day

Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00847262

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The third hospital affiliated to the Third Military Medical University
Chongqing, China, 400042
Sponsors and Collaborators
Third Military Medical University
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Principal Investigator: Zhiming Zhu, MD, PhD The third hospital affiliated to the Third Military Medical University. China

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Responsible Party: Zhiming Zhu, Chief of the Department of Hypertension & Endocrinology, Third Military Medical University Identifier: NCT00847262     History of Changes
Other Study ID Numbers: HOT-2
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013
Keywords provided by Zhiming Zhu, Third Military Medical University:
Abdominal obesity
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists