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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

February 17, 2009
December 15, 2013
June 2008
December 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00847262 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Trial Comparing Metabolic Effects of Telmisartan and Amlodipine on Hypertensive Patients With Obesity and Diabetes
Hypertension With Obesity Trial: Diabetes Mellitus Branch

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Obesity
  • Diabetes
  • Drug: Temisartan
    Temisartan, initial dose: 40 mg per day, Max dose: 160 mg per day
  • Drug: Amlodipine
    Amlodipine, initial dose: 5 mg per day, Max dose: 10 mg per day
  • Experimental: Telmisartan Group
    Telmisartan intervention group
    Intervention: Drug: Temisartan
  • Active Comparator: Amlodipine Group
    Amlodipine intervention group
    Intervention: Drug: Amlodipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00847262
HOT-2
Yes
Zhiming Zhu, Third Military Medical University
Third Military Medical University
Not Provided
Principal Investigator: Zhiming Zhu, MD, PhD The third hospital affiliated to the Third Military Medical University. China
Third Military Medical University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP