Clinical trial NCT00847262: Trial Comparing Metabolic Effects of Telmisartan and Amlodipine on Hypertensive Patients With Obesity and Diabetes
Official title: Hypertension With Obesity Trial: Diabetes Mellitus Branch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Obesity
Diabetes
Keywords: Hypertension
Abdominal obesity
Diabetes
Treatment
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure
timeFrame: Baseline, 24 weeks(End of trial)
measure: Metabolic profiles, including lipid profile and blood glucose
timeFrame: Baseline, 24 weeks(End of trial)
Secondary outcomes:
measure: Abdominal fat assessed by CT
timeFrame: Baseline, 24 weeks(End of trial)
measure: Obesity parameters, including waist circumference (WC) and body mass index (BMI)
timeFrame: Baseline, 24 weeks(End of trial)
measure: Incidents of side effects between groups
timeFrame: Baseline, 24 weeks(End of trial)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The third hospital affiliated to the Third Military Medical University
Study officials:
affiliation: The third hospital affiliated to the Third Military Medical University. China
name: Zhiming Zhu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: