Metabolic Syndrome XNCT02531334
Effects of TA-65, a Telomerase Activator on Metabolic Syndrome
A study testing TA-65 in people with Metabolic Syndrome X, run by University of Connecticut at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 32 to 70 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- TA-65
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
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.
Read the detailed description
Short telomeres are strongly linked to increased risk of cardiovascular disease and diabetes, indications where tissue aging and senescence play significant roles. Shorter leukocyte telomere length has been linked to impaired glucose tolerance, Type 2 Diabetes, and coronary heart disease. Telomere length and telomerase activity have been shown to be significantly lower in CAD patients. Telomere length may play an important role in predicting cardiovascular disease and diabetes. TA-65 may not only ameliorate the symptoms associated with these disease states, but be a preventive measure as well.
In this study, the researchers will investigate whether telomerase activator (TA)-65 can also improve the metabolic dysregulations associated with metabolic syndrome including oxidative stress, inflammation, high blood pressure and dyslipidemias.
- Conditions
- Metabolic Syndrome X
- Being tested
- TA-65
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TA-65Dietary supplement
2 pills of TA-65 or placebo daily for 12 weeks. Subjects will be monitored weekly for side effects and every 4 weeks for compliance and safety monitoring. The whole intervention is a randomized double blind study for a duration of 27 weeks; 12 weeks for TA-65 or placebo allocated randomly and after a 3 week washout period, allocation to the alternate supplement TA-65 or placebo.
| Study group | Role | What they receive |
|---|---|---|
| TA-65 | Experimental | TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each Receives: Dietary Supplement: TA-65 |
| Placebo | Placebo comparator | Placebo will be provided to volunteers for 12 weeks, two pills per day of 8 mg each Receives: Dietary Supplement: TA-65 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma insulin
The supplement is expected to decrease insulin resistance in metabolic syndrome patients
Measured: 27 weeks
Secondary outcomes (1)
Plasma HDL cholesterol
The supplement is expected to increase plasma HDL cholesterol
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Luz Fernandez, University of Connecticut
- Investigators
- Maria Luz Fernandez, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531334
- Sponsor's protocol ID
- H14-278
- Status last verified
- Oct 2018
- First submitted
- 20 Aug 2015
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Maubaret CG, Salpea KD, Jain A, Cooper JA, Hamsten A, Sanders J, Montgomery H, Neil A, Nair D, Humphries SE; HIFMECH consortium, Simon Broome Research Group. Telomeres are shorter in myocardial infarction patients compared to healthy subjects: correlation with environmental risk factors. J Mol Med (Berl). 2010 Aug;88(8):785-94. doi: 10.1007/s00109-010-0624-3. Epub 2010 Apr 11.
PubMed 20383691
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TA-65, a Telomerase Activator on Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02531334
- Acronym / sponsor ID
- H14-278
- Conditions
- Metabolic Syndrome X
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Short telomeres are strongly linked to increased risk of cardiovascular disease and diabetes, indications where tissue aging and senescence play significant roles. Shorter leukocyte telomere length has been linked to impaired glucose tolerance, Type 2 Diabetes, and coronary heart disease. Telomere length and telomerase activity have been shown to be significantly lower in CAD patients. Telomere length may play an important role in predicting cardiovascular disease and diabetes. TA-65 may not only ameliorate the symptoms associated with these disease states, but be a preventive measure as well.
In this study, the researchers will investigate whether telomerase activator (TA)-65 can also improve the metabolic dysregulations associated with metabolic syndrome including oxidative stress, inflammation, high blood pressure and dyslipidemias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TA-65 | Experimental | Dietary Supplement: TA-65TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each |
| Placebo | Placebo comparator | Dietary Supplement: TA-65Placebo will be provided to volunteers for 12 weeks, two pills per day of 8 mg each |
Who may qualify
- Ages
- 32 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TA-652 pills of TA-65 or placebo daily for 12 weeks. Subjects will be monitored weekly for side effects and every 4 weeks for compliance and safety monitoring. The whole intervention is a randomized double blind study for a duration of 27 weeks; 12 weeks for TA-65 or placebo allocated randomly and after a 3 week washout period, allocation to the alternate supplement TA-65 or placebo. | Dietary supplement | Placebo, TA-65 |
Primary outcome
Plasma insulin
Time frame: 27 weeks
The supplement is expected to decrease insulin resistance in metabolic syndrome patients
1 secondary outcome
Plasma HDL cholesterol
Time frame: 27 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Results publication: PubMed 20383691Maubaret CG, Salpea KD, Jain A, Cooper JA, Hamsten A, Sanders J, Montgomery H, Neil A, Nair D, Humphries SE; HIFMECH consortium, Simon Broome Research Group. Telomeres are shorter in myocardial infarction patients compared to healthy subjects: correlation with environmental risk factors. J Mol Med (Berl). 2010 Aug;88(8):785-94. doi: 10.1007/s00109-010-0624-3. Epub 2010 Apr 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Luz Fernandez, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TA-65 in people with Metabolic Syndrome X, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma insulin (time frame: 27 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.