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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 17, 2009

Last Updated Date

December 15, 2013

Start Date ^ICMJE

June 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00847262 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Hypertension With Obesity Trial: Diabetes Mellitus Branch

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension
Obesity
Diabetes

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Telmisartan Group
Telmisartan intervention group

Intervention: Drug: Temisartan
Active Comparator: Amlodipine Group
Amlodipine intervention group

Intervention: Drug: Amlodipine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

June 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00847262

Other Study ID Numbers ^ICMJE

HOT-2

Has Data Monitoring Committee

Yes

Responsible Party

Zhiming Zhu, Third Military Medical University

Study Sponsor ^ICMJE

Third Military Medical University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Zhiming Zhu, MD, PhD

The third hospital affiliated to the Third Military Medical University. China

Information Provided By

Third Military Medical University

Verification Date

December 2013

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

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