Genomas, LLC

Genomas Clinical Studies

 

 

PIMS PhyzioType System: Psychotropic-Induced Metabolic Symptoms

Physiogenomic Analysis of Antipsychotic Therapies and their Metabolic Side Effects

 

 

 

SINM PhyzioType System: Statin Induction + Neuro-Myopathy

DNA Diagnostic System for Statin Safety and Efficacy

 

 

 

GLIM PhyzioType System: Glucose + Insulin Modulators

Clinical Registry and DNA Repository for Personalized Management of Diabetes Mellitus

 

 

 


                  

PIMS PhyzioType System: Psychotropic-Induced Metabolic Symptoms

Physiogenomic Analysis of Antipsychotic Therapies and their Metabolic Side Effects

(Hartford Hospital IRB # 002412)

Principal Investigator: Gualberto Ruańo, MD, Genomas

Co-Investigators:  John Goethe, MD, Institute of Living, Hartford Hospital

                       Jose de Leon, MD, University of Kentucky

Background:  A $1.4M Phase II, 3-year, peer-reviewed, SBIR grant was awarded by the National Institute of Mental Health, NIH to investigate DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics. The grant will finance completion of development of the company's PIMS PhyzioType System. A consortium of Genomas, The Institute of Living and The University of Kentucky Mental Health Research Center was formed to complete this grant.

 

PATIENT INFORMATION

What is the purpose of this research?

The purpose of this study is to assess patients treated with the antipsychotics Zyprexa®, Risperdal®, Seroquel®, Geodon® and Abilify® to identify genetic variations more commonly found in individuals who develop metabolic syndrome, a condition that includes changes in blood lipids, blood glucose, blood pressure, and body weight. If this study does identify related genes, genetic tests will be developed to provide patients and health care professionals with tools to identify those patients who are at risk of developing adverse side effects to antipsychotics.

There may be reasons why you are not allowed to take part in this study, as follows:

§      You have not taken any of the medications noted above for 50% of the time in the previous month, and a minimum of 50% of the time in the previous 3 months.

§      The study doctor or staff will discuss these and any other reasons why you may not be allowed to enter the study.

What procedures are involved with participation in this research study?

If you take part in the study, you will need to do the following:

§      One visit to the Institute of Living (lasting 1-2 hours)

§      A blood sample will be taken with a needle from your arm vein during the visit.  The amount of blood drawn will be 5 to 10 ml (less than 2 tablespoons).

§      During the visit you will have a brief physical examination that will include measurements of height, weight, hip and waist circumference, blood pressure, and heart rate.

§      During the visit, you will complete a questionnaire asking about your health and treatment history and the history of your family. An interviewer will ask you additional questions about these topics.

Which of these procedures is experimental? 

Of the items listed above, none are experimental.

Where will participation take place?

Study visits will take place in the Burlingame Center for Psychiatric Research at the Institute of Living, Hartford and at the University of Kentucky, Lexington. About 1000 people will be in the study. 

How long will participation last?

Your participation will last 1-2 hours.

For more information, or to enroll, contact:

Hartford site:                                                           University of Kentucky site:

John Goethe, MD      or             Steven Woolley, PhD       Jose de Leon, MD

Institute of Living                            Institute of Living                  Department of Psychiatry

200 Retreat Avenue                      200 Retreat Avenue             College of Medicine, University of Kentucky

Hartford, CT  06109                     Hartford, CT  06109            UK MHRC at Eastern State Hospital

Phone: (860) 545-7118                (860) 545-7329                    627 West Fourth St, Lexington, KY40508 Email:jgoethe@harthosp.org              swoolle@harthosp.org       (859) 246-7563 jdeleon@uky.edu

 

SINM PhyzioType System: Statin Induction + Neuro-Myopathy

DNA Diagnostic System for Statin Safety and Efficacy

(Hartford Hospital IRB # 002532)

Principal Investigator: Gualberto Ruańo, MD, Genomas

Background:  This 2.5-year, peer-reviewed, Small Business Innovative Research (SBIR) grant from the National Institute of General Medical Studies, NIH, will finance completion of the development of the company's SINM PhyzioType System. The award of $1.2M in the SBIR Fast Track Phase I+II category brings together a consortium that includes Genomas, Hartford Hospital, The Rogosin Institute (Weill Cornell Medical School, New York), and the University of California, San Francisco.

 

PATIENT INFORMATION

What is the purpose of this research?

Lipitor®, Zocor®, and Crestor® are statin drugs commonly taken by patients with high cholesterol to prevent heart disease.  Statins lower cholesterol, but by different amounts in different patients.  Sometimes statins cause muscle pain, cramps or weakness. This study will examine genetic differences in the blood of patients taking statins to see if a person’s DNA is a good predictor of how well the statins lower cholesterol and how well it predicts muscle discomfort.  If the researchers find the possible connections this might lead to additional treatment studies and eventually a way to decide which statin is best for a patient.  About 1000 people will be in the study. 

What procedures are involved with participation in this research study?

Only persons who have taken one of the three statins mentioned above may participate. Your participation in this study will involve the following procedures:

§      You will give a small blood sample, about two tablespoons, for DNA analysis and measurement of enzymes relevant to muscle damage such as creatine kinase. (A person trained in blood drawing will insert a needle into a vein in your arm to collect the blood.  The investigators will code your blood sample with a unique study number so the sample does not directly identify you.)

§      Your medical records will be reviewed to determine your history of muscle ache/pain/discomfort, cholesterol test results, enzyme results, and statin medications.

§      A member of the research staff may ask you about your symptoms, or you may be asked to complete a questionnaire about muscle symptoms.

§      You will be in the study only for 1-2 hours.

For more information, or to enroll, contact:

Hartford site:                       Rogosin Clinic site:                           UCSF site:

Rick Seip, PhD                 B.J. Sloan RN                                  Alan Wu, PhD            

Tel: 860-545-5005              Tel: 212-702 9600 ext. 109               Tel: (415) 206-3540

rseip@harthosp.org           Sloanb@mail.rockefeller.edu            wualan@labmed2.ucsf.edu


GLIM PhyzioType System: Glucose + Insulin Modulators

Clinical Registry and DNA Repository for Personalized Management of Diabetes Mellitus

(The Hospital of Central Connecticut IRB # 0703)

Principal Investigator: James Bernene, MD, The Hospital of Central Connecticut, Joslin Clinic

Background:  This ongoing project evaluates the safety and efficacy of glitazone therapy in Type 2 diabetic outpatients.  Genomas has joined with The Hospital of Central Connecticut, Joslin Clinic Affiliate to create a clinical registry for patients receiving thiazolidinedione (glitazone) medications in order to identify physiogenomic associations predictive of glitazone efficacy and side effects. 

 

PATIENT INFORMATION

What is the purpose of this research?

1) To create a clinical registry of medical information for research subjects using  thiazolidinedione (glitazone) medications used to treat Diabetes Mellitus (Actos® and Avandia®). This medical information will be studied to determine whether DNA (genetic material) can be used to guide diabetes management.

2) To examine the side effects of thiazolidinedione medications. The DNA of research subjects will be compared to discover DNA sequences (genetic material) that could predict effectiveness of glitazones on blood sugar control and could predict the side effects of glitazones that are known to include weight gain, edema (fluid accumulation), and elevated liver function tests.  The study is purely observational and does not involve any clinical interventions as a result of DNA typing data.  DNA analysis performed on a single blood sample is experimental.  Actos® and Avandia® are FDA approved medications used to control blood sugars in the person with diabetes. 

What procedures are involved with participation in this research study?

Your participation will involve the following procedures: 

§      Five (5) ml (one teaspoon) of blood will be collected and used for DNA analysis.  The sample will be collected only once.

§      Testing your blood sugar fasting (nothing to eat or drink for a minimum of 8 hours), postprandial (2 hours after one meal each day) and each night at bedtime.

§      Recording of medical information including medical history, routine laboratory results, response to treatment, symptoms, possible side effects, complications and medication history.  This will occur at the time you enter the study and at each of your routine doctor’s visits to the Joslin Diabetes Center for a minimum of one (1) year. 

Possible Risks and Discomforts: The risks from drawing blood are occasional light-headedness, bruising and discomfort at the site of the blood draw.  There is also a slight risk of infection. The total amount of blood that will be taken during the entire study is one (1) teaspoon.

Possible Benefits: There is no direct benefit to you and to others from participating in this research.  Results of the DNA tests will not be made available to you or your physician or put in your medical record since they are experimental.  You may contribute to a better understanding of how DNA-guided diabetes management works.

Other Treatments: You will receive the usual and established treatments for your diabetes.  There are no treatment exclusions as part of this study.

For more information, or to enroll, contact:

Terri McInnis RN, CDE, CCRC

The Hospital of Central Connecticut, New Britain, CT

860-224-5900 ext. 2223

TMcInnis@THOCC.ORG




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