Information related to:
Trial ID: NCT04229030
Title: RZL-012 for Dercum's Disease Lipomas

Raziel Therapeutics is conducting a study to test the effectiveness and safety of RZL-012 f in people with Dercum’s Disease lipomas.
RZL-012 is a synthetic molecule that is intended to reduce fat content in injected areas. Each eligible and enrolled person with Dercum’s disease will have RZL-012 injected into several lipomas, according to lipoma size. Lipoma dimensions and pain will be monitored during the study together with safety monitoring.
The study will include 38 people with Dercum’s disease. Nineteen (19) people will be injected with RZL-012 and 19 will receive the placebo. Enrolled people with Dercum’s disease will not know which treatment they are receiving. Each enrolled person will be dosed and followed up for 84 days. At the end of the study, the study codes will be opened. People receiving placebo will be offered to have their lipomas injected with RZL-012. This is optional. If subjects decide to take part in the extension part, they will be followed up for an additional 84 days.

The study will be conducted in 3 clinical sites in the USA: LA-CA, O’Fallon-MO, Durham-NC.
If you wish to take part in the study and you meet the following criteria, please contact Dr. Karen Herbst for additional details on the study.

contactbonniemack@gmail.com
 Criteria to for eligibility:

You must be 18-70 years old. You must have at least 4 painful lipomas. You have to be considered healthy according to medical history and physical examination with fasting glucose concentration <200mg/dL. You must agree to use a double barrier contraceptive device for the 4 weeks after your last study treatment (for example; condom and spermicide). You must be able to understand and comply with study requirements. You must be willing and able to attend all study visits on time. You must sign and date an IRB approved informed consent indicating that you are aware of the investigational nature of the study.

​subcutaneous adipose tissue (SAT) Disorder Specialist

Lipedema
Dercum disease
Madelung Disease
​Angiolipomatosis
Familial multiple lipomatosis

I am officially retired from the university of arizona but maintain an email:
karenherbst@email.arizona.edu

i am currently setting up a private practice and will post information here when the time arrives to start scheduling appointments.
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Canadian patients:
The Canadian Health Care Insurer (Pacific Blue Cross) has agreed to cover 100% of the cost of manual lymph drainage treatments, garments and sequential pneumatic lymph pump after a patient of mine with stage 3 lipedema wrote to the review committee (they were paying 50% previous).  

British Columbian provincial government may pay for her liposuction.


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MY GOALS AS YOUR PROVIDER

WHAT I PROVIDE:
1. HOPE - based on my years of experience with ATDs, I have a lot of ideas for you to try that people with ATDs before you have tried and found out to work for them in many instances.  With medical science roaring ahead, there are always new things to try.


2. EXPERIENCED FINGERS - Doctors and nurses, PAs and other healthcare providers were never taught how to examine fat.  I know how and learn more as time goes on.


3. A PLAN - you will leave my clinic visit with ideas on how to continue to improve your life.


4. A PARTNERSHIP - I learn from you as well so feel free to share your ideas with me on what works for you and what does not work; I will listen.

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IF YOU ARE FLYING IN TO TUCSON FROM OUT OF THE STATE OR OUT OF THE COUNTRY:


PLEASE BE SURE TO GET FLIGHT INSURANCE OR AN OPEN END TICKET IN CASE I AM CALLED OUT OF TOWN OR BECOME ILL.


I AM HAPPY TO WRITE A LETTER FOR YOU TO GET YOUR TICKET CHANGED BUT USUALLY THIS ONLY WORKS IF YOU HAVE INSURANCE OR AN OPEN END TICKET.
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I am not able to keep up with phone calls and emails at this time.  

WHAT TO BRING TO AN APPOINTMENT

1. ALL Labs in ATDs tend to be normal.  Bring any abnormal labs, a lipid profile, an ESR, CRP, CH50.

2. Any imaging that provides information on your ATD.

3. A copy of the Overview form filled out.  Click on the underlined words to download pdf, fill out and bring with you to the appointment. 

4. The fax number of any physician or healthcare provider you want your note sent to. 

5. Wear clothes you can easily take on and put on. Do not wear your compression if you are expecting an exam - you can put on after the exam.

6. LABS
Bring any labs you have completed within the past year.

a. Lipid panel; if on lipid lowering medications, also get homocysteine and Lp(a) levels

b. Marker of inflammatory mediators in the blood causing blood cells to precipitate quicker: Erythrocyte sedimentation rate (ESR)

c. Stable marker of inflammatory repair: C-reactive protein (CRP)

d. CH50 - checks if your complement (clotting system) is normal or elevated.  The complement system is part of the inflammatory cascade and when other markers of inflammation/repair tend to be negative, this one can turn out to be positive and guide us in your treatment.

e. Angiotensin converting enzyme (ACE) level - this is a non-specific marker of inflammation and can turn out to be positive when other markers are negative.  If it is positive, it does not mean you have sarcoid, a condition in which ACE levels are high - it just means you have inflammation.  Your healthcare provider may want a chest X-ray to evaluate for sarcoid if this lab comes back positive.

f. IgE, IgA, IgG levels - many people with fat disorders have low IgG levels.  IF this lab comes back low, check a IgG subclass panel to find which IgG is low.  You may want to see an Immunologist/Allergist if you have low IgG levels.

g. Vitamin D level - vitamin D helps fight off infections, improves bone mineral density and tends to be low in people who have excess fat.

h. If you have a lot of chemical sensitivities, allergies, itching, flushing, edema, or think you might have a mast cell activation disorder, please check:
   -Serum tryptase (Quest Diagnostics; 34484); CPT code 83520
   -Plasma histamine (Quest Diagnostics; 6586X); CPT code 83088     
   -Prostaglandin D2 (FPGD2 90154); Mayo clinic; CPT code 
       84150 - http://www.mayomedicallaboratories.com/test-catalog/print/90154) 
    -Factor VIII activity (Quest Diagnostics; 8353); CPT code 85240
    -24 hour urine for the histamine metabolite N-methylhistamine (Quest Diagnostics; 83011); CPT Codes 82570, 83789; Includes creatinine)
 Must be off all H2 antagonist/blockers (ranitidine, cimetidine, famotidine), all antihistamines (benadryl, zyrtec, allegra, claritin, quercetin and others) and off all NSAIDs (ibuprofen, naproxen, ketoprofen and others), and off aspirin (ASA) for 7 days to get the tests in "h".

i. If you have fatigue
***Please get a TSH to check the thyroid
***Check the hypothalamic pituitary adrenal axis circadian rhythm and function with four salivary cortisol levels: 8AM, noon, 4PM and before bed through Labcorp test number 502124 (four serial samples); CPT code 82533

IMAGING
If you have significant edema (lymphedema) and have never had a lymphoscintigraphy scan but want one to better understand your lymphatic anatomy and physiology, your primary care physician can order one for you either locally or at the University of Arizona.  Please call well ahead of time as they book 1-2 months out.  Lymphoscintigraphy can be used to detect blockages in the lymph vessels or the absence of lymph vessel. This test requires a small amount of radioactive material to be injected through a small needle into the hand or foot. Except for minor discomfort (some people with chronic pain experience more pain) and skin injection, this test is not otherwise dangerous or painful. 
More here: http://www.uahealth.com/library/sections/article/lymphoscintigraphy 

PULMONARY
If shortness of breath is a main component of your ATD and you will be seeing me, please ask your healthcare provider to order pulmonary function testing (PFTs).  If you have had a CT or MRI of your lungs, please bring the actual scan and report with you.  I am working with the Cardiothoracic Imaging Chief and she and her colleagues have taken an interest in ATDs.
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PLACES TO STAY
Please rely on your own decision for a hotel to meet your personal needs.


Sincerely,
Karen L. Herbst, PhD, MD

Below you see macrophages (roundish dark dots which are the nuclei of the macrophages) or collagen (that thick pinkish colored area in the picture to the right) surrounding blood vessels from people with Dercum's disease.

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Please support me on iGive: http://www.iGive.com/DercDz

Dr. Karen L. Herbst

Dr. Herbst was voted as one of San Diego’s top doctors in San Diego Magazine 2009 and in the "Guide to Americs's Top Physicians" in 2013 - see: consumersresearchcncl.org/ 
She was a guest on the Doctor's Show where she discussed the Cyclic Variations in Adaptive Conditioning (CVAC) Process as a unique form of exercise eventually publishing on the ability of the CVAC Process to reduce pain in a pilot study of Dercum's disease. Dr. Herbst was the research Physician on Mystery Diagnosis in June 2010 highlighting a young man with Dercum's Disease (The Man with 1000 Lumps).