Metabolic Syndrome Clinical Trial
— TRISTANOfficial title:
A Prospective Observational Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
NCT number | NCT04650152 |
Other study ID # | FENO5002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 27, 2020 |
Est. completion date | November 12, 2021 |
Verified date | December 2021 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is a prospective observational program within the frames of which Tricor (fenofibrate) is prescribed to patients with hypertriglyceridemia within a routine procedure as a part of the combination therapy with statins.
Status | Completed |
Enrollment | 1000 |
Est. completion date | November 12, 2021 |
Est. primary completion date | November 12, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Men and women = 18 years of age. - Triglycerides level above 2,3 mmol/l. - Patients having been prescribed fenofibrate 145 mg for at least 6 months AND who have been taking fenofibrate 145 mg no more than 3 days at the time of enrollment into the study. - Patient who take statins at the time of enrollment into the study. - Patients who have signed the informed consent to participate in this program. Exclusion Criteria: - Patients who took last dose within previous treatment course of fenofibrate less than 3 months ago. - Statin-intolerant patients. - Female patients during pregnancy or breastfeeding. - diabetes mellitus (DM) type 1 - Participation in any other clinical or non-clinical study/program at present or within the latest 30 days. - Patients with any other clinical states that make him/her ineligible for the program on the study doctor's opinion based on clinical assessment. - Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality). - Known gallbladder disease. - Severe chronic kidney disease (creatinine clearance <60 ml/min). - Chronic or acute pancreatitis. - Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen. - Hypersensitivity to the active substance(s) or to any of the excipients. - Allergic to peanut or arachis oil or soya lecithin or related products due to risk of hypersensitivity reactions. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | City Polyclinic #14 (branch office) | Barnaul | |
Russian Federation | Clinical Diagnostic Centre | Bryansk | |
Russian Federation | Diagnostic Centre | Cheboksary | |
Russian Federation | Polyclinic #1 | Cheboksary | |
Russian Federation | Polyclinic | Chelyabinsk | |
Russian Federation | Polyclinic #1 | Chelyabinsk | |
Russian Federation | Medical center | Ekaterinburg | |
Russian Federation | Polyclinic | Ekaterinburg | |
Russian Federation | City Polyclinic #4 | Irkutsk | |
Russian Federation | Clinical hospital | Irkutsk | |
Russian Federation | Polyclinic #1 | Irkutsk | |
Russian Federation | Medical center | Kaliningrad | |
Russian Federation | Polyclinic | Kazan | |
Russian Federation | Polyclinic | Kemerovo | |
Russian Federation | Polyclinic #2 of Hospital #4 | Kemerovo | |
Russian Federation | City polyclinic 7/ ID 015 | Krasnoyarsk | |
Russian Federation | Dispensary | Krasnoyarsk | |
Russian Federation | City Polyclinic # 166 (branch office #2) | Moscow | |
Russian Federation | City Polyclinic #166 (branch office #3) | Moscow | |
Russian Federation | City Polyclinic #170 (branch office #2) | Moscow | |
Russian Federation | City Polyclinic #23 | Moscow | |
Russian Federation | Clinical Diagnostic Centre #1 (branch office #4) | Moscow | |
Russian Federation | Medical center | Moscow | |
Russian Federation | Polyclinic | Moscow | |
Russian Federation | City Polyclinic | Moscow region | |
Russian Federation | Medical center | Moscow region | |
Russian Federation | Regional hospital | Moscow region | |
Russian Federation | Polyclinic | Nizhniy Tagil | |
Russian Federation | Medical center | Nizhny Novgorod | |
Russian Federation | Polyclinic #40 | Nizhny Novgorod | |
Russian Federation | Polyclinic of City Hospital #40 | Nizhny Novgorod | |
Russian Federation | Medical center | Nizhny Novgorod region | |
Russian Federation | Polyclinic #4 ??? 6 | Orenburg | |
Russian Federation | Clinical cardiologic dispensary | Perm | |
Russian Federation | Medical center | Perm | |
Russian Federation | Medical center | Perm | |
Russian Federation | Medical center | Perm | |
Russian Federation | City Polyclinic #1 | Rostov-on-Don | |
Russian Federation | City Polyclinic #1 (branch office) | Rostov-on-Don | |
Russian Federation | City Polyclinic #7 | Rostov-on-Don | |
Russian Federation | Polyclinic of City Hospital #20 | Rostov-on-Don | |
Russian Federation | City Polyclinic #109 | Saint Petersburg | |
Russian Federation | City Polyclinic #109 | Saint Petersburg | |
Russian Federation | City Polyclinic #116 | Saint Petersburg | |
Russian Federation | City polyclinic #54 / ID 065 | Saint Petersburg | |
Russian Federation | City Polyclinic #71 | Saint Petersburg | |
Russian Federation | City Polyclinic #96 | Saint Petersburg | |
Russian Federation | Medical unit | Saint Petersburg | |
Russian Federation | Polyclinic #34 | Saint Petersburg | |
Russian Federation | City policlinic #3 | Samara | |
Russian Federation | Clinical hospital | Samara | |
Russian Federation | Medical center | Samara | |
Russian Federation | City Polyclinic #2 | Saratov | |
Russian Federation | Medical center | Smolensk | |
Russian Federation | City hospital | Ufa | |
Russian Federation | Polyclinic of City hospital #21 | Ufa | |
Russian Federation | City polyclinic 18 /ID 038 | Volgograd | |
Russian Federation | Polyclinic # 2 | Volgograd | |
Russian Federation | Polyclinic #28 | Volgograd | |
Russian Federation | Polyclinic #30 | Volgograd | |
Russian Federation | City hospital #4 | Voronezh | |
Russian Federation | City Polyclinic #7 | Voronezh | |
Russian Federation | Polyclinic | Yaroslavl |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of TG at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1. | Triglycerides will be represented in mmol/L and change of TG will be displayed as mean difference of TG at Visit 3 vs. Visit 1. | 6 months | |
Secondary | Change of LDL level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1 | Low-density lipoproteins (LDL) will be represented in mmol/L and change of LDL will be displayed as mean difference of LDL at Visit 3 vs. Visit 1. | 6months | |
Secondary | Change of lipid profile parameters (TC, HDL, non-HDL) at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1 | Lipid profile includes total cholesterol (TC), high-density lipoproteins (HDL) and non-HDL. The lipid profile parameters will not be combined into 1 value and will be reported as separate values but results will be presented in the same unites of measure (mmol/L). Non-HDL is calculated as total cholesterol minus HDL cholesterol. Change of each lipid profile parameter will be displayed as mean difference of the result at Visit 3 vs. Visit 1. | 6 months | |
Secondary | Change of LDL level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1. | Low-density lipoproteins (LDL) will be represented in mmol/L and change of LDL will be displayed as mean difference of LDL at Visit 2 vs. Visit 1. | 3 months | |
Secondary | Change of lipid profile parameters (TC, TG, HDL, non-HDL) at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1. | Lipid profile includes total cholesterol (TC), high-density lipoproteins (HDL) and non-HDL. The lipid profile parameters will not be combined into 1 value and will be reported as separate values but results will be presented in the same unites of measure (mmol/L). Non-HDL is calculated as total cholesterol minus HDL cholesterol. Change of each lipid profile parameter will be displayed as mean difference of the result at Visit 2 vs. Visit 1. | 3 months | |
Secondary | Change of C-reactive protein level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1 | ?hange of C-reactive protein (CRP) will be displayed as mean difference of CRP at Visit 3 vs. Visit 1. | 6 months | |
Secondary | Change of C-reactive protein level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1 | ?hange of C-reactive protein (CRP) will be displayed as mean difference of CRP at Visit 2 vs. Visit 1. | 3 months | |
Secondary | The average score on each of 8 scales of Short Form Survey Instrument (SF)-36 quality of life questionnaire at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1. | The 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively, so that a high score defines a more favorable health state. Items in the same scale are averaged together to create the 8 scale scores.
Patients will complete this self-reported questionnaire, containing 36 items, for evaluation of the quality of life after 6 months of treatment. |
6 months | |
Secondary | The average score on each of 8 scales of Short Form Survey Instrument (SF)-36 quality of life questionnaire at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1 | The 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively, so that a high score defines a more favorable health state. Items in the same scale are averaged together to create the 8 scale scores.
Patients will complete this self-reported questionnaire, containing 36 items, for evaluation of the quality of life after 3 months of treatment. |
3 months |
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