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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group T | Experimental | Telmisartan |
|
| Group T+M | Experimental | Telmisartan plus Metformin |
|
| Group C | Experimental | Candesartan |
|
| Group C+M | Experimental | Candesartan pus Metformin |
|
| Group A | Active Comparator | Amlodipine |
|
| Group A+M | Experimental | Amlodipine plus Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan plus Metformin | Drug | Telmisartan 80mg 1/d, Metformin 250mg 2/d |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Baseline, 24 weeks(End of trial) | |
| Metabolic profiles, including lipid profile and blood glucose | Baseline, 24 weeks(End of trial) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiming Zhu, MD, PhD | The third hospital affiliated to the Third Military Medical University. China | Principal Investigator |
| Zhiming Zhu, MD, PhD | The third hospital affiliated to the Third Military Medical University. China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The third hospital affiliated to the Third Military Medical University | Chongqing | 400042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22525206 | Result | 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. |
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| Telmisartan |
| Drug |
Telmisartan 80mg 1/d |
|
|
| Candesartan | Drug | Candesartan 8mg daily |
|
|
| Candesartan plus Metformin | Drug | Candesartan 8mg 1/d Metformin 250mg 2/d |
|
| Amlodipine | Drug | Amlodipine 5mg 1/d |
|
|
| Amlodipine plus Metformin | Drug | Amlodipine 5mg 1/d, Metformin 250mg 2/d |
|
| Insulin resistance assessed by fasting serum insulin and HOMA-IR |
| Baseline, 24 weeks(End of trial) |
| Incidents of side effects between groups | Baseline, 24 weeks(End of trial) |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009765 | Obesity |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D008687 | Metformin |
| C081643 | candesartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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