Metabolic SyndromePhase 4NCT03504735
Caduet and TLC Intervention in Metabolic Syndrome
A Phase 4 study testing Therapeutic Lifestyle Change and Caduet Pill in people with Metabolic Syndrome, run by The University of Texas Medical Branch, Galveston.
Trial summary
To evaluate the effectiveness of Caduet in addition to therapeutic life-style change (TLC) intervention in resolving metabolic syndrome fifty three individuals were randomized to TLC intervention study with or without Caduet therapy for 12 months. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Therapeutic Lifestyle Change and Caduet Pill
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2005to 28 Feb 2016
- Phase
- Phase 4
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BP ≥130/85
- Metabolic syndrome per NCEP-ATP III revised (3/5 criteria)
- Men and women age 40-65
Who cannot join
- Inability to sign a consent form.
- Unwillingness to complete the protocol for the duration of 15 months
- Unwillingness of primary care physician to participate in the program
- Patients already on hypercholesterolemia agent
- Fasting plasma glucose above 126 mg/dL or current treatment for diabetes.
- If the physician believes the patient should be started on antihypertensive regimen.
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- Creatinine clearance <50ml/min.
- Therapy with anticoagulants
- Pregnant/lactating women (pre-menopausal women should be on birth control pill)
- AST/ALT > x3 upper limit of normal
- Evidence of cholelithiasis
- Use of oral anticoagulants
- Cancer
- Recent cardiovascular event (<6months)
- Substance abuse
- Since there is no translator, non-English speaking subjects will not be enrolled in the study.
About this study
Official title: Effect of Caduet and TLC Intervention on Metabolic Parameters
To evaluate the effectiveness of Caduet in addition to therapeutic life-style change (TLC) intervention in resolving metabolic syndrome fifty three individuals were randomized to TLC intervention study with or without Caduet therapy for 12 months. The participants underwent monthly visits with investigators to obtain vital signs, and to undergo TLC counseling. Metabolic parameters were measured before and after intervention.
Read the detailed description
Single center, investigator driven, double blinded, randomized with Caduet 5/10mg vs placebo. The participants visited with investigators on a monthly bases to evaluate the BP, weight, and obtain the waist measurements, and counseling. OGTT was performed at the beginning and the end of the study. Lipid and glucose parameters were measured 5 times in duration of the study period.
Exercise physiologists and dietitians completed the baseline evaluations and provided recommendations throughout the study period in person, via phone or e-mail: per subject preference. VO2 max was measured at the beginning and end of the study. Pedometers dispensed to encourage physical activity.
- Conditions
- Metabolic Syndrome
- Being tested
- Therapeutic Lifestyle Change, Caduet Pill, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Lifestyle ChangeBehavioural
Also called TLC
Monthly consult with a dietitian and fitness instructor.
Caduet PillDrug
Also called 5Mg-10Mg Tablet
Take once daily.
PlaceboDrug
Also called Oral Tablet
Take once daily.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Lifestyle Change+Placebo | Placebo comparator | Therapeutic Life-style change intervention with Placebo pills. Receives: Behavioral: Therapeutic Lifestyle Change; Drug: Placebo |
| Therapeutic Lifestyle Change+Caduet | Active comparator | Therapeutic Lifestyle Change intervention with Caduet pills. Receives: Behavioral: Therapeutic Lifestyle Change; Drug: Caduet Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution or improvement of metabolic syndrome.
HDL >40mg/dl for men, >50 mg/dl for women. Glucose <100mg/dl Waist circumference <40 in in men, <35 in in women Triglycerides <150mg/dl BP <130/80 Attainment of 1 or more of these goals will result in resolution or improvement of metabolic syndrome
Measured: 12 months
Secondary outcomes (1)
Weight loss
5% decrease compared to that at the start of the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 May 2005
- Primary completion1 Jan 2009
- Study completion28 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, University of Texas Southwestern Medical Center
- Responsible party
- Sponsor
- Investigators
- Nicola Abate, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504735
- Sponsor's protocol ID
- 082005-005
- Status last verified
- Apr 2018
- First submitted
- 15 Mar 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Caduet and TLC Intervention on Metabolic Parameters
- ClinicalTrials.gov ID
- NCT03504735
- Acronym / sponsor ID
- 082005-005
- Conditions
- Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Pfizer, University of Texas Southwestern Medical Center
- Study start
- 1 May 2005 (actual)
- Primary completion
- 1 Jan 2009 (actual)
- Study completion
- 28 Feb 2016 (actual)
- First posted
- 20 Apr 2018 (actual)
- 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.
To evaluate the effectiveness of Caduet in addition to therapeutic life-style change (TLC) intervention in resolving metabolic syndrome fifty three individuals were randomized to TLC intervention study with or without Caduet therapy for 12 months. The participants underwent monthly visits with investigators to obtain vital signs, and to undergo TLC counseling. Metabolic parameters were measured before and after intervention.
Detailed description
Single center, investigator driven, double blinded, randomized with Caduet 5/10mg vs placebo. The participants visited with investigators on a monthly bases to evaluate the BP, weight, and obtain the waist measurements, and counseling. OGTT was performed at the beginning and the end of the study. Lipid and glucose parameters were measured 5 times in duration of the study period.
Exercise physiologists and dietitians completed the baseline evaluations and provided recommendations throughout the study period in person, via phone or e-mail: per subject preference. VO2 max was measured at the beginning and end of the study. Pedometers dispensed to encourage physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Lifestyle Change+Placebo | Placebo comparator | Behavioral: Therapeutic Lifestyle Change, Drug: PlaceboTherapeutic Life-style change intervention with Placebo pills. |
| Therapeutic Lifestyle Change+Caduet | Active comparator | Behavioral: Therapeutic Lifestyle Change, Drug: Caduet PillTherapeutic Lifestyle Change intervention with Caduet pills. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BP ≥130/85
- Metabolic syndrome per NCEP-ATP III revised (3/5 criteria)
- Men and women age 40-65
Key exclusion criteria (16 listed)
- Inability to sign a consent form.
- Unwillingness to complete the protocol for the duration of 15 months
- Unwillingness of primary care physician to participate in the program
- Patients already on hypercholesterolemia agent
- Fasting plasma glucose above 126 mg/dL or current treatment for diabetes.
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 |
|---|---|---|
| Therapeutic Lifestyle ChangeAlso: TLCMonthly consult with a dietitian and fitness instructor. | Behavioural | Therapeutic Lifestyle Change+Caduet, Therapeutic Lifestyle Change+Placebo |
| Caduet PillAlso: 5Mg-10Mg TabletTake once daily. | Drug | Therapeutic Lifestyle Change+Caduet |
| PlaceboAlso: Oral TabletTake once daily. | Drug | Therapeutic Lifestyle Change+Placebo |
Primary outcome
Resolution or improvement of metabolic syndrome.
Time frame: 12 months
HDL >40mg/dl for men, >50 mg/dl for women. Glucose <100mg/dl Waist circumference <40 in in men, <35 in in women Triglycerides <150mg/dl BP <130/80 Attainment of 1 or more of these goals will result in resolution or improvement of metabolic syndrome
1 secondary outcome
Weight loss
Time frame: 12 months
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 13 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Nicola Abate, MD principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Therapeutic Lifestyle Change and Caduet Pill in people with Metabolic Syndrome, run by The University of Texas Medical Branch, Galveston.
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 3 inclusion and 16 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 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Resolution or improvement of metabolic syndrome. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2018.