α-ketoglutarate in Patients With Hypertension

Hypertension Clinical Trial

— AKGHTN  

Official title:

The Effects of α-ketoglutarate on Blood Pressure and Endothelial Function in Hypertensive Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445244
• Other study ID #: KY-IIT-2024-001
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Xia Wenhao, MD, PhD
• Phone: +86 15818193120
• Email: xiawhao[@]mail.sysu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardiovascular and cerebrovascular diseases are most terrible killers endangering the health of Chinese residents, and hypertension is the most important risk factor. Hypertension related microvascular rarefaction and endothelial dysfunction are the common pathological basis and initiation of cardiovascular and cerebrovascular disease. Therefore, reducing blood pressure and delaying or reversing endothelial dysfunction is an effective way to treat hypertension and prevent cardiovascular disease. Alpha-ketoglutarate (αKG) is a critical metabolic intermediate in the tricarboxylic acid (TCA) cycle, involves in diverse cellular biological activities, such as central metabolism, antioxidative defense, epigenetic regulation, and cell proliferation. The latest research found that with the growth of age, the level of αKG is decreasing, and increasing the content of αKG can prolong the life of multiple species including human. Recent clinical trials found that αKG supplementation can effectively improve the level of αKG in cells, delay aging, improve the metabolic process of cells without adverse reactions. However, the effect of αKG supplementation on reducing blood pressure and protecting vascular endothelial function has not been reported. Therefore, this study aims to focus on hypertension, a major chronic disease, and to observe the effects of αKG supplementation on endothelial function and blood pressure in patients with hypertension, so as to provide a new treatment strategy for hypertension and associated endothelial dysfunction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1? Primary hypertension (office blood pressure: systolic blood pressure 130~159 mmHg and/or diastolic blood pressure 80~99 mmHg, which meets the diagnostic criteria of hypertension class 1 of 2018AHA hypertension guidelines) and accompanied by vascular dysfunction (FMD<5%); 2? Age between 18 and 65 years old; 3, Not using any drugs and dietary supplements that affect blood pressure and vascular endothelial function in the last 3 months, mainly including antihypertensive, lipid-lowering, hypoglycemic drugs and natural plant extract antioxidants; 4? Voluntarily sign the informed consent form after fully understanding the purpose and process of the study, disease characteristics, drug effects, methods of relevant examinations, and potential risks/benefits of the study.

Exclusion Criteria:

1. Presence of secondary hypertension (those who have been diagnosed with secondary hypertension in the past and have not been definitively cured, and if secondary hypertension is suspected, a complete examination is required to exclude common secondary hypertension, including renal hypertension (renal parenchymal lesions, renal artery stenosis), primary aldosteronism, Cushing's syndrome, pheochromocytoma, aortic constriction, and severe obstructive sleep apnea);

2. Acute myocardial infarction within the past 6 months;

3. recent history of stroke (within 6 months); 4, Dilated heart disease, hypertrophic cardiomyopathy, rheumatic heart disease, congenital heart disease, severe heart valve disease (severe valve stenosis and or regurgitation);

5. patients with a combination of serious physical illnesses, such as cancer; 6, Severe hepatic or renal dysfunction (ALT and or AST) = 3 times the upper limit of normal, or dialysis end-stage renal disease or eGFR < 30 ml/min/1.73 m2, or serum creatinine > 2.5 mg/dL [> 221 µmol/L]); 7. Symptomatic heart failure or reduced left ventricular ejection fraction (<40%) within the past 6 months; 8. History of hypersensitivity to the study drug or to its components after administration; 9. Participating in other clinical studies; 10. Patients with mental illness who are unable to cooperate; 11, Pregnant, lactating or expectant mothers;

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• Alpha-ketoglutarate supplied as 1000mg capsule
AKG Double Wood® + lifestyle modification AKG Double Wood®: 500mg, qd, for one months. Lifestyle modification: intake 1400-1600 kcal/day: 54% carbohydrates, 24% proteins, 22% lipids, 108 mg cholesterol, 35 g fiber; avoid smoking and alcohol consumption; performing aerobic activity 4 days per week such as 45 min on a stationary bicycle.

Behavioral:
• Behavioral: Lifestyle modification
Lifestyle modification: intake 1400-1600 kcal/day: 54% carbohydrates, 24% proteins, 22% lipids, 108 mg cholesterol, 35 g fiber; avoid smoking and alcohol consumption; performing aerobic activity 4 days per week such as 45 min on a stationary bicycle.

Locations

Country	Name	City	State
China	Wenhao Xia	Guangxi	Nanning

Sponsors (1)

Lead Sponsor	Collaborator
Jun Tao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of aKG on flow mediated dilation (FMD)	Change of FMD between aKG-treated participants and non-aKG-treated participants	Up to 1 month
Primary	Effect of aKG on brachial-ankle pulse wave velocity (baPWV)	Change of baPWV between aKG-treated participants and non-aKG-treated participants	Up to 1 month
Secondary	Effect of aKG on blood pressure	Change of systolic blood pressure and diastolic blood pressure between aKG-treated participants and non-aKG-treated participants	Up to 1 month
Secondary	Effect of aKG on serum aKG levels	Change of serum aKG levels between aKG-treated participants and non-aKG-treated participants	Up to 1 month
Secondary	Effect of aKG on retinal vascular density	Change of retinal vascular density between aKG-treated participants and non-aKG-treated participants	Up to 1 month