Clinical trial NCT00538486: A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients
Official title: Which is the Best Treatment for Non-diabetic Hypertension With Obesity: Telmisartan, Amlodipine or Candesartan, Alone or Plus MEtformin? (HOT-ACME 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Obesity
Keywords: Hypertension
Abdominal obesity
Treatment
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 360
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: The epidemic of obesity is associated with a considerable rise in the incidence of the metabolic syndrome, type 2 diabetes mellitus, and hypertension. Insulin resistance plays an important role in the pathogenesis of obesity related hypertension. These patients are at high risk to suffer from cardiovascular events. However, current guidelines for treatment of hypertension do not provide specific recommendation for the pharmacotherapy of obese hypertensive patients due to lack of prospective randomized intervention studies in non-diabetic obese hypertensive patients.

Aside from their antihypertensive effects, angiotensin II receptor blockers (ARB) were shown to improve insulin sensitivity. Furthermore, metformin is commonly used to treat the obese type 2 diabetes mellitus. Metformin can also lower body weight and increase insulin sensitivity. In a prospective, double-blind, double-dummy, randomized, parallel-group study, we will evaluate the effects of ARB (telmisartan and candesartan) or amlodipine combination with metformin on weight gain, visceral fat, and metabolic parameters in obese hypertensive patients without diabetes mellitus compared with obese hypertensives on ARB or amlodipine treatment alone. This study will help to develop future comprehensive treatment strategies and guidelines for obesity related hypertension.


Eligibility criteria: Inclusion Criteria:

* Grade 1 or 2 hypertension: 140mmHg≤SBP\<180mmHg, and/or 90mmHg≤DBP\<110mmHg
* Waist circumference higher than 90cm in men, 80cm in women

Exclusion Criteria:

* Diabetes
* Grade 3 hypertension: SBP≥180mmHg, or DBP≥110mmHg
* known allergy or hypersensitivity to trial drugs
* Myocardial infarction or cerebrovascular accident in the year preceding the trial
* Clinical Congestive Heart Failure
* History of hepatitis or cirrhosis
* History of kidney disease

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: Insulin resistance assessed by fasting serum insulin and HOMA-IR
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
affiliation: The third hospital affiliated to the Third Military Medical University. China
name: Zhiming Zhu, MD, PhD
role: STUDY_DIRECTOR
References:
citation: He H, Zhao Z, Chen J, Ni Y, Zhong J, Yan Z, Li Y, Liu D, Pletcher MJ, Zhu Z. Metformin-based treatment for obesity-related hypertension: a randomized, double-blind, placebo-controlled trial. J Hypertens. 2012 Jul;30(7):1430-9. doi: 10.1097/HJH.0b013e328353e249.