CLINICAL TRIAL

Atorvastatin for Lipidemia

Waitlist Available · 18 - 65 · All Sexes · New Haven, CT

This study is evaluating whether a lipid sensitive statin can improve cardiovascular health in transgender men.

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About the trial for Lipidemia

Eligible Conditions
Hypertension · Hyperlipidemias

Treatment Groups

This trial involves 2 different treatments. Atorvastatin is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Atorvastatin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
placebo
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin
FDA approved

Side Effect Profile for Treatment

Treatment
Show all side effects
Postoperative bleeding
3%
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT02084069) in the Treatment ARM group. Side effects include: Postoperative bleeding with 3%.

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Two groups (n=10 each) of subjects will be recruited to complete this study: 1) trans men between 18 and 35 years; 2) cisgender women between 18 and 35 years (Controls). They will have a body mass index (BMI) 18-30 kg·m-2. Our subjects will be matched on BMI and IR, using hemoglobin A1c and Homeostatic Model Assessment of Insulin Resistance technique (HOMA-IR) in order to isolate testosterone effects from other co-morbidities that may impact BP, sympathetic activity or endothelial function. Subjects will have HbA1c of 4-5.9% and a HOMA-IR of 0.5-1.4 to be included in the study. Subjects who smoke, have diabetes, or BP>140/90 will be excluded. Subjects will not be taking medications during the study, including any insulin sensitizing or CV medications.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 30 minutes
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 30 minutes.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Atorvastatin will improve 11 primary outcomes and 6 secondary outcomes in patients with Lipidemia. Measurement will happen over the course of 2 hours.

Diastolic Blood Pressure
2 HOURS
DBP, measured in mmHg
Systolic Blood Pressure
2 HOURS
SBP, measured in mmHg
Cardiovagal baroreflex sensitivity (BRS)
2 HOURS
This is determined as a function of change in R-R interval (from EKG) over systolic blood pressure during rest and regular breathing. Expressed in Units.
Muscle Sympathetic Nerve activity (MSNA)
2 HOURS
measured using microneurography and expressed in bursts/min or bursts/100 heart beats
serum estradiol (S[E2])
5 MINUTES
estrogen is measured in pg/ml. This should be suppressed in our trans subjects, and low in our cis subjects. In the latter, low estrogen should indicate the early follicular phase of the menstrual cycle.
plasma endothelin-1, (S[ET-1])
5 MINUTES
endothelial health, increased ET-1 levels in the blood indicate damage to the endothelium
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can lipidemia be cured?

While the effects of lipid on mortality is uncertain, it may be the result of some lipid lowering medications causing a reduction in cardiovascular disease. The role of statins in cancer is unclear and their use in pregnancy and breast feeding needs to be exercised with caution by clinicians.

Anonymous Patient Answer

What causes lipidemia?

This paper reviews lipidemia causes and treatments as defined by literature. It provides clinical examples for the management of lipotoxicity that are of high clinical relevance to physicians and medical students.

Anonymous Patient Answer

What are the signs of lipidemia?

It is known that an elevated total cholesterol level is an independent risk factor that increases the risk of both coronary heart diseases and vascular diseases such as ischemic stroke. Lipid levels in the patient's blood depend on how often the patient eats, exercise, and drinks and also whether or not they take any medications. To evaluate the presence of any type of lipid in the blood and also to check for heart diseases a detailed history, a physical examination, as well as laboratory tests are advisable. These tests can also help clinicians make diagnoses, and thus, implement the necessary treatment for the disease depending on what type of diagnosis has been established.

Anonymous Patient Answer

What are common treatments for lipidemia?

Lipid therapy is commonly used in lipidemic patients. It is not effective for preventing cardiovascular disease in statin-treated individuals, suggesting the need to tailor therapy beyond LDL-reduction goals.

Anonymous Patient Answer

How many people get lipidemia a year in the United States?

There are around 20 million people who develop lipidemia a year and this is likely to grow to over 40 million within the next 25 years.

Anonymous Patient Answer

What is lipidemia?

The most prevalent definition of hyperlipidemia in the Framingham Heart Study, used by nearly all investigators, was the >2.5rd-99th percentile limits for chylomicron, LDL, and plasma cholesterol. Using the >2rd-99th percentile limits for Hcy, TGs, triglycerides, and ApoB, Hcy was more prevalent than the other lipid measurements in both the men and the women, which suggests that it may be of a greater concern.

Anonymous Patient Answer

What is the average age someone gets lipidemia?

There are a number of potential reasons for the apparent age of onset of lipoprotein [elevations], including the possibility of age-dependent change in the biological pathways that lead to cholesterol accumulation.

Anonymous Patient Answer

How does atorvastatin work?

Lipid-lowering medication is effective in preventing adverse cardiovascular outcomes associated with metabolic syndrome among patients with coronary heart disease who have diabetes, atherosclerosis, or a history of diabetes.

Anonymous Patient Answer

Does lipidemia run in families?

Most cases of hyperlipidemia run in families; it may be due to common genetic factors. Data from a recent study strengthen the concept that a large number of sporadic hyperlipidemic cases are familial and underscore the importance of screening family members of patients with familial hyperlipidemias for hyperlipidemia.

Anonymous Patient Answer

What is the primary cause of lipidemia?

In the developed world as well as in our patient population, lipidemia seems to be a more complex pathophysiological condition involving systemic factors; and so a multifactorial approach is always necessary.

Anonymous Patient Answer

What is the latest research for lipidemia?

Diabetes (type 1 or 2) is a significant risk factor for cardiovascular disease and accounts for about 10% of all deaths in the United States. Although the connection between diabetes and other forms of hyperlipidaemia has been made well known, research was largely restricted to the effects of diabetes on dyslipidaemia and atherosclerosis. Findings from a recent study of clinical trials performed in the United States on this topic have been very positive, however, and most researchers believe that the current guidelines for lowering the LDL (bad) level in diabetic patients are too ambitious. Lipidemia is an important issue, however, and, unfortunately, there currently is too little data available for us to develop consensus regarding the optimal treatment regimen.

Anonymous Patient Answer

Have there been other clinical trials involving atorvastatin?

A significant number of trial reports published in the last decade have used atorvastatin to assess its clinical impact or in conjunction with conventional antihypertensive treatment, and there are numerous reports in the literature. There is strong evidence to suggest efficacy or safety considerations for patients receiving atorvastatin at this dosage.

Anonymous Patient Answer
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