Effects of TA-65, a Telomerase Activator on Metabolic Syndrome

Completed · Not applicable · Has a placebo group

Conditions studied: Metabolic Syndrome X

In brief

This study is being conducted to evaluate the efficacy of TA-65, a purified extract of Astragalus root, on insulin resistance, oxidative stress, and inflammation in individuals classified with metabolic syndrome.

Key facts

Study ID

NCT02531334

Run by

University of Connecticut

People needed

40

Starts

2015-08-01

Expected to finish

2018-06-01

Last updated by the study team

2018-10-10

Who can join

Age: 32 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 32 to 70 years
• Men and women
• Proficiency in English
• Postmenopausal women, or women of childbearing age (premenopausal) must be using some form of contraception or have had a hysterectomy
• Classification of metabolic syndrome according to the Adult treatment panel (ATP) III criteria, meaning that individuals have 3 or more of the following characteristics:
• Waist circumference >102 cm for men or > 88 cm for women
• Triglycerides > 150 mg/d L
• HDL cholesterol < 40 mg/dL for men or < 50 mg/dL for women
• Blood pressure > 130/85 mm Hg or systolic ≥ 130 or diastolic ≥ 85*
• Fasting blood glucose > 100 mg/dL *Or taking blood pressure medications

You may not qualify if…

• Participants who do not fulfill the classification of metabolic syndrome, which means that they do not have 3 or more of the 5 characteristics previously mentioned
• Participants with a body mass index (BMI) > 40 kg/m2
• Current or past diagnosis of liver disease, renal disease, diabetes, cancer, stroke, heart disease, severe infectious disease, or autoimmune diseases (including but not limited to multiple sclerosis, lupus, and rheumatoid arthritis)
• Women who are pregnant, lactating, or planning to become pregnant
• Use of any glucose-lowering prescriptions or supplements, such as Sulfonylureas (Glucotrol, Amaryl, chlorpropamide, gliclazide, glimepiride, glipizide, glyburide), Thiazolidinediones (Avandia, ACTOS, rosiglitazone, pioglitazone), Meglitinides (Prandin, Starlix), Biguanides (Metformin), Alpha-glucosidase inhibitors (Precose, Glyset, acarbose, miglitol), Dipeptidyl peptidase (DPP)-4 inhibitors (Januvia, Onglyza, alogliptin, linagliptin, saxagliptin, sitagliptin), Glucagon-like peptide (GLP-1) antagonists (exenatide, liraglutide), Meglitinides (nateglinide, repaglinide), sodium glucose cotransporter (SGLT)-2 inhibitors (canagliflozin) or high dose chromium or cinnamon supplements
• Use of immunosuppressants, including azathioprine, cyclophosphamide, basiliximab, cyclosporine, everolimus, daclizumab, infliximab, mercaptopurine, methotrexate, muromonab-cluster of differentiation3 (CD3), mycophenolate, pimecrolimus, rituximab, tacrolimus, sirolimus, prednisone, methylprednisone, dexamethasone, hydrocortisone (not topical), or prednisolone
• Use of anticoagulants, including factor Xa inhibitors (rivaroxaban, apixaban), thrombin inhibitor (dabigatran), vitamin K antagonist (warfarin), heparin, low-molecular weight heparin, fondaparinux, or antiplatelets (aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticagrelor, ticlopidine)
• Use of other categories of drugs, including methadone, Suboxone, monoamine oxidase (MAO) inhibitors, or lithium.
• Use of any combination drug product containing any of the individual drugs listed above
• Participants who have been consistently taking vitamin, mineral, or multivitamin supplements prior to recruitment may be admitted into the study if they plan to maintain their current supplement program. However, subjects may not participate if they begin taking a new supplement during the 27-week study period.
• Fasting plasma triglycerides ≥ 500 mg/dL, glucose ≥ 126 mg/dL, or blood pressure > 145/100 mm Hg or systolic > 145 mm Hg or diastolic > 100 mm Hg

Where it is running

• University of Connecticut — Storrs, Connecticut, United States

Full record on ClinicalTrials.gov

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