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

Obesity Clinical Trial

— HOT-DM  

Official title:

Hypertension With Obesity Trial: Diabetes Mellitus Branch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847262
• Other study ID #: HOT-2
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2009
• Last updated: December 15, 2013
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: December 2013
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Information Consent Signed

• Aged 30~70 years

• For whom without anti-hypertensive therapy in 2 weeks:140mmHg=SBP<180mmHg,?90mmHg=DBP<110mmHg. For whom with anti-hypertensive therapies in 2 weeks:SBP<180mmHg, ?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 ?~? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Obesity

Intervention

Drug:
• Temisartan
Temisartan, initial dose: 40 mg per day, Max dose: 160 mg per day
• Amlodipine
Amlodipine, initial dose: 5 mg per day, Max dose: 10 mg per day

Locations

Country	Name	City	State
China	The third hospital affiliated to the Third Military Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure		Baseline, 24 weeks(End of trial)	No
Primary	Metabolic profiles, including lipid profile and blood glucose		Baseline, 24 weeks(End of trial)	No
Secondary	Abdominal fat assessed by CT		Baseline, 24 weeks(End of trial)	Yes
Secondary	Obesity parameters, including waist circumference (WC) and body mass index (BMI)		Baseline, 24 weeks(End of trial)	Yes
Secondary	Incidents of side effects between groups		Baseline, 24 weeks(End of trial)	Yes