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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT00847262
First received: February 17, 2009
Last updated: December 15, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Hypertension
Obesity
Diabetes
Drug: Temisartan
Drug: Amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypertension With Obesity Trial: Diabetes Mellitus Branch

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: Baseline, 24 weeks(End of trial) ] [ Designated as safety issue: No ]
  • Metabolic profiles, including lipid profile and blood glucose [ Time Frame: Baseline, 24 weeks(End of trial) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Abdominal fat assessed by CT [ Time Frame: Baseline, 24 weeks(End of trial) ] [ Designated as safety issue: Yes ]
  • Obesity parameters, including waist circumference (WC) and body mass index (BMI) [ Time Frame: Baseline, 24 weeks(End of trial) ] [ Designated as safety issue: Yes ]
  • Incidents of side effects between groups [ Time Frame: Baseline, 24 weeks(End of trial) ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847262

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

No publications provided

Responsible Party: Zhiming Zhu, Chief of the Department of Hypertension & Endocrinology, Third Military Medical University
ClinicalTrials.gov Identifier: NCT00847262     History of Changes
Other Study ID Numbers: HOT-2
Study First Received: February 17, 2009
Last Updated: December 15, 2013
Health Authority: China: Ministry of Health

Keywords provided by Third Military Medical University:
Hypertension
Abdominal obesity
Diabetes
Treatment

Additional relevant MeSH terms:
Hypertension
Obesity
Diabetes Mellitus
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Telmisartan
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on October 01, 2014