Trial Comparing Metabolic Effects of Telmisartan and Amlodipine on Hypertensive Patients With Obesity and Diabetes (HOT-DM)
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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 |
Estimated Study Completion Date: | June 2009 |
Estimated 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
|
Ages Eligible for Study: | 30 Years to 70 Years |
Genders Eligible for Study: | Both |
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
China | |
The third hospital affiliated to the Third Military Medical University | |
Chongqing, China, 400042 |
Principal Investigator: | Zhiming Zhu, MD, PhD | The third hospital affiliated to the Third Military Medical University. China |
No publications provided
Responsible Party: | Zhiming Zhu, MD, PhD, The third hospital affiliated to the Third Military Medical University. China |
ClinicalTrials.gov Identifier: | NCT00847262 History of Changes |
Other Study ID Numbers: | HOT-2 |
Study First Received: | February 17, 2009 |
Last Updated: | February 20, 2009 |
Health Authority: | China: Ministry of Health |
Keywords provided by Third Military Medical University:
Hypertension Abdominal obesity Diabetes Treatment |
Additional relevant MeSH terms:
Diabetes Mellitus Hypertension Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Amlodipine |
Telmisartan Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 26, 2012