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
