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

Hypertension With Obesity Trial: Diabetes Mellitus Branch

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00847262
Acronym
HOT-DM
Enrollment
120
Registered
2009-02-19
Start date
2008-06-30
Completion date
2009-06-30
Last updated
2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypertension, Obesity

Keywords

Hypertension, Abdominal obesity, Diabetes, Treatment

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.

Interventions

DRUGAmlodipine

Amlodipine, initial dose: 5 mg per day, Max dose: 10 mg per day

DRUGTemisartan

Temisartan, initial dose: 40 mg per day, Max dose: 160 mg per day

Sponsors

Third Military Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Blood PressureBaseline, 24 weeks(End of trial)
Metabolic profiles, including lipid profile and blood glucoseBaseline, 24 weeks(End of trial)

Secondary

MeasureTime frame
Abdominal fat assessed by CTBaseline, 24 weeks(End of trial)
Obesity parameters, including waist circumference (WC) and body mass index (BMI)Baseline, 24 weeks(End of trial)
Incidents of side effects between groupsBaseline, 24 weeks(End of trial)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026