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

Tracking Information
First Submitted Date ICMJE	February 17, 2009
First Posted Date ICMJE	February 19, 2009
Last Update Posted Date	December 17, 2013
Study Start Date ICMJE	June 2008
Actual Primary Completion Date	December 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 18, 2009)	Blood Pressure [ Time Frame: Baseline, 24 weeks(End of trial) ]; Metabolic profiles, including lipid profile and blood glucose [ Time Frame: Baseline, 24 weeks(End of trial) ]
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; (submitted: February 18, 2009)	Abdominal fat assessed by CT [ Time Frame: Baseline, 24 weeks(End of trial) ]; Obesity parameters, including waist circumference (WC) and body mass index (BMI) [ Time Frame: Baseline, 24 weeks(End of trial) ]; Incidents of side effects between groups [ Time Frame: Baseline, 24 weeks(End of trial) ]
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; Intervention Model: Parallel Assignment; Masking: None (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 Arms	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
Actual Enrollment ICMJE; (submitted: February 18, 2009)	120
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	June 2009
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	30 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
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
PRS Account	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