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

NCT00847262 | Completed Phase 4 DMC

• 1 other identifier: HOT-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Obesity; Diabetes

Keywords

Hypertension; Abdominal obesity; Diabetes; Treatment

Outcome Measures

Primary Outcomes (2)

• Blood Pressure

  Baseline, 24 weeks(End of trial)

• Metabolic profiles, including lipid profile and blood glucose

  Baseline, 24 weeks(End of trial)

Secondary Outcomes (3)

• Abdominal fat assessed by CT

  Baseline, 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 groups

  Baseline, 24 weeks(End of trial)

Study Arms (2)

Telmisartan Group

EXPERIMENTAL

Telmisartan intervention group

Drug: Temisartan

Amlodipine Group

ACTIVE COMPARATOR

Amlodipine intervention group

Drug: Amlodipine

Interventions

Temisartan DRUG

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

Telmisartan Group

Amlodipine DRUG

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

Amlodipine Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

The third hospital affiliated to the Third Military Medical University

Chongqing, 400042, China

Location

MeSH Terms

Conditions

Hypertension; Obesity; Diabetes Mellitus; Obesity, Abdominal

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhiming Zhu, MD, PhD

  The third hospital affiliated to the Third Military Medical University. China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Department of Hypertension & Endocrinology

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

CN (1)