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http://www.medscape.com/viewarticle/481406
DHEA Replacement May Be Beneficial for Hypoadrenal Women
Yael Waknine
Dehydroepiandrosterone (DHEA) replacement therapy improves
general health perception, arousal, and learning efficiency in hypoadrenal
women, according to the results of a randomized, double-blind,
placebo-controlled, crossover study presented at the 86th annual meeting of The
Endocrine Society in New Orleans, Louisiana.
The study investigated the possibility that 50 mg daily of DHEA may improve the
quality of life in hypoadrenal women taking glucocorticoid and mineralocorticoid
replacement.
"Rather than looking at people who’ve got low DHEA levels for replacement, we
actually chose hypoadrenal women — women who have Addison’s disease or who have
had their [adrenal] glands taken out — who do not produce DHEA," Ketan K.
Dhatariya, MD, from the Mayo Clinic and Foundation in Rochester, Minnesota, and
lead author of the study, told Medscape. "So results are...actually due to DHEA
and not to any endogenous hormones [the women] may have."
The investigators enrolled 33 hypoadrenal women aged 21 to 80 years. The women
were treated with 50 mg of DHEA or placebo daily for 12 weeks followed by a
two-week washout period between phases.
General health perception was measured using the Memory Functioning, Changes in
Sexual Functioning, and Health Status questionnaires, as well as the Beck
Depression Inventory. Women receiving DHEA showed improvement in health
perception compared with those receiving placebo (-0.19 ± 0.83 vs. 0.66 ± 0.92;
P = .03), as well as significantly higher arousal scores (8.5 ± 1.98 vs. 7.67 ±
2.19; P = .02).
Likewise, Auditory Verbal Learning Test scores showed significant improvement
after the DHEA phase (54.87 ± 10.23 vs. 51.42 ± 9.39; 95% confidence interval,
0.63 - 6.21; P = .03).
"In this study we measured a huge number of psychological variables, most of
[the results] being...negative. However, there were three positives; [subjects]
showed an increase in sexual arousal scores,...an increase in learning
efficiency,...and an increase in general health perception when taking DHEA as
compared with placebo," Dr. Dhatariya noted.
"Our conclusions were that while this was a broadly negative study, [DHEA] did
improve scores in those three areas," Dr. Dhatariya said. "A trial of 50 mg DHEA
daily would be warranted in those women who have got adequate glucocorticoid and
mineralocorticoid replacement yet feel subjectively that they have a lower
quality of life."
This study was supported by the National Institutes of Health.
ENDO 2004: Abstract P2-572. Presented June 17, 2004.
Reviewed by Gary D. Vogin, MD
http://www.ivanhoe.com/channels/p_channelstory.cfm?storyid=9900
Hormone Offsets Harmful Effects of Aging
(Ivanhoe Newswire) -- Researchers at Washington
University School of Medicine in St. Louis have found the hormone
dehydroepiandrosterone (DHEA) may be able to offset the increase in abdominal
fat and accompanying increased risk for diabetes that often occur with advancing
age.
The study authors explain levels of DHEA peak at about age 20 and then gradually
decline. They say by the time we are 70, we have only about 20 percent of the
peak amount circulating in the body, which has been associated with the harmful
effects of aging.
Dennis T. Villareal, M.D., and John O. Holloszy, M.D., set out to examine
whether complications of aging could be reversed if DHEA levels in elderly
people were returned to the levels of their youth. The study included 56 people
with an average age of 71. For six months, half of the group was randomly
assigned to receive a placebo while the other half received 50 milligrams of
DHEA daily.
Using MRI measurements, the researchers found that DHEA supplementation resulted
in a decrease in abdominal fat of 10.2 percent in women and 7.4 percent in men.
It also resulted in a 6-percent decrease in fat below the skin surface for men
and women.
"Among the different fat stores, visceral [abdominal] fat is specifically
considered potent and metabolically active because its blood drains directly to
the liver," the authors say. "Fatty acids from visceral fat get deposited in the
liver and other organs and then mediate the decrease in insulin action that
leads to an increased risk for diabetes."
In addition, patients receiving DHEA showed an improvement in insulin action.
This shows a protective effect of DHEA against insulin resistance caused by a
high-fat diet and the natural decrease in insulin responsiveness that occurs
with older age, the study authors say.
Dr. Villareal and Dr. Holloszy are now recruiting people for a larger study on
the effects of one year of DHEA replacement.
SOURCE: The Journal of the American Medical Association, 2004;292:2243-2248
U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH
NIH News
National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK)
http://www.niddk.nih.gov/
EMBARGOED FOR RELEASE
Thursday, November 25, 2004
2:00 p.m. ET
CONTACT:
Marcia Vital
301-496-3583
SCIENTISTS GENERATE HUMAN ISLET PRECURSOR CELLS IN CULTURE FROM CADAVERIC
INSULIN-PRODUCING CELLS
Scientists at the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK), one of the National Institutes of Health (NIH), have induced
human insulin-producing cells of the pancreas to revert to islet precursor
cells. These precursor cells are capable of expansion and appear to naturally
and efficiently differentiate into clusters of islet-like cells. This work may
help to clarify the natural lifecycle of the beta cell and may eventually have
applications for diabetes treatment. The study appears on-line today in
"Science" Express, the rapid publication web site of the journal "Science".
Insulin-producing beta cells exist in spherical clusters, called islets, in the
pancreas. Research shows that beta cells are born, die, and are replaced by
other beta cells throughout a person's lifetime, but little is known about the
process. When the body cannot produce or replace beta cells, insulin levels fall
causing blood glucose levels to rise and diabetes results. This study's findings
may eventually have implications for islet transplantation, an experimental
treatment for type 1 diabetes.
"This is a step forward in the field, but we're still a long way from using this
knowledge to develop a therapy for diabetes," says lead author, Marvin C.
Gershengorn, M.D., Scientific Director of NIDDK's Division of Intramural
Research and Chief of the institute's Clinical Endocrinology Branch. "For one
thing these differentiated cells do not function as well as the original cells.
They don't produce as much insulin and they are not as adaptable to changes in
the environment. For another thing, we grew these cells in a culture that is not
optimal for use in humans, so we are not ready to transplant these cells into
people. Still, I am encouraged."
The researchers removed islets from human cadaver pancreata, as is done before
islet transplantation, and exposed these islets to a medium containing fetal
bovine serum. Over 17 days the cells in the clusters migrated out until the
original islets were depleted. These migrating islet cells, identified as
insulin-expressing cells, then transformed into more primitive precursor cells
that do not produce insulin.
These new cells, called human islet-derived precursor cells (hIPCs), reproduce
easily. The researchers observed that the hIPCs showed substantial proliferative
potential, doubling in number about every 60 hours, and by 90 days had expanded
by almost a billion fold. Not stem cells, these precursor cells are transitional
cells since they originated from insulin-producing islets. The authors note,
however, that this finding does not preclude the possible existence of islet
stem cells, as yet undiscovered.
"We knew that islets regenerate," says Gershengorn. "When old islets die out,
the pancreas produces new ones to take their place. So, we thought, there must
be cells within the pancreas that can reproduce and efficiently differentiate
into hormone-producing cells or even intact islets. The challenge was to
identify them and make them work."
After isolating significant numbers of hIPCs and showing that they are highly
proliferative, the researchers wanted to see if they could reverse the process
and induce the new cells to become insulin-producing again. In the second stage
of their study, the researchers exposed cultures of hIPCs to a serum-free
medium. They saw a highly efficient, gradual transition from precursor hIPCs to
epithelial islet-like cell aggregates over a period of several weeks. The cell
aggregates produced insulin and other hormones, but at much lower levels than
that of human islets - about 0.02 percent of the level of insulin produced by
healthy islets. Still, the islet-like cells did show many of the characteristics
of the original beta cells. "It appears, therefore, that hIPCs are
pre-determined to transition back into hormone-producing cells under minimal
conditions in culture," added Gershengorn.
One of NIDDK's goals for long-term diabetes research is to better understand the
beta cell and how it regenerates. These findings may eventually have
implications for diabetes treatments, including islet transplantation. Islet
transplantation involves the infusion of islets derived from donor pancreata
into a person with complicated type 1 diabetes. The hope is that some of the
transplanted cells will survive in the pancreas and continue producing insulin.
A major obstacle to the wider use of islet transplantation as a treatment for
type 1 diabetes is the small number of donor pancreata that become available for
use each year and the large number of islets needed for transplantation. The
NIDDK is focusing its research on understanding the beta cell and its
regeneration and on efforts to develop alternative sources of beta cells.
The researchers hope that future studies will corroborate their findings and
address some of the unanswered questions. For example, the researchers plan to
conduct studies to try to define the optimal environmental conditions to grow
precursor cells and to stimulate them to differentiate into hormone-producing
cells. Their goal is to design a cellular environment as close as possible to
the natural environment of a healthy human pancreas. Another challenge is to
develop a culture medium that does not rely on animal serum, so cells grown in
the lab can be transplanted back into people with a minimum risk of side
effects.
More information on islet transplantation can be found on the NIDDK web site:
http://diabetes.niddk.nih.gov/dm/pubs/pancreaticislet/
Accredited media can access the journal article on the "Eurekalert!" web site:
http://www.eurekalert.org/
This NIH News Release is available online at:
http://www.nih.gov/news/pr/nov2004/niddk-25.htm
A Study to Assess SOM230 in Patients with Pituitary
Cushing’s Disease
This study is currently recruiting patients.
| Sponsored by: |
Novartis
Pharmaceuticals |
| Information provided by: |
Novartis
Pharmaceuticals |
Purpose
The study treatment period is 15 days in length and includes patients with
pituitary Cushing’s disease who are candidates for surgical intervention as
well as and patients who have recurrent Cushing’s post operatively.
| Condition |
Treatment or Intervention |
Phase |
Cushing's Syndrome
|
Drug: SOM230 s.c.
|
Phase II
|
MedlinePlus related topics: Adrenal Gland Disorders
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single
Group Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Open Label Study to Assess the
Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in
patients with Cushing’s disease
Further Study Details:
Expected Total Enrollment: 26
Study start: April 2004
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for
Study: Both
Criteria
Inclusion Criteria:
- Patients with pituitary Cushing’s disease within the two months prior to
study entry
- Patients for whom written informed consent to participate in the study has
been obtained
- Female patients of child bearing potential who have not undergone
clinically documented total hysterectomy and/or ovariectomy, or tubal
ligation must agree to use barrier contraception throughout the course of
the study, and for one month after the study has ended
Exclusion Criteria:
- Female patients who are pregnant or lactating
- Patients who have been previously treated with certain medications may be
required to be without certain medications prior to entering the study
- Poorly controlled diabetes mellitus as indicated by the presence of
ketoacidosis or HgbA1C > 10
- Patients who have congestive heart failure, unstable angina, cardiac
arrhythmia or history of acute MI less than one year prior to the study
entry or clinically significant impairment in cardiovascular function
(e.g. blood pressure of 190/100mmHg or greater)
- Patients with chronic liver disease
- Patients with clotting disorders or abnormal blood counts
- History of immuno-compromise, including a positive HIV test result
- Patients with active gall bladder disease
- Patients who have participated in any clinical investigation with an
investigational drug within 1 month prior to dosing
- Patients with active malignant disease (with the exception of basal cell
carcinoma or carcinoma in situ of the cervix)
Location and Contact Information
California
Cedars-Sinai Pituitary Center, Los Angeles, California, 90048, United
States; Not yet recruiting
Shlomo Melmed, MD 310-423-4691
Shlomo Melmed, MD, Principal Investigator
Massachusetts
Massachusetts General Hospital NE Unit, Boston, Massachusetts, 02114,
United States; Not yet recruiting
Beverly Biller, MD 617-726-3870
Beverly Biller, MD, Principal Investigator
Pennsylvania
University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United
States; Not yet recruiting
Peter Snyder, MD 215-898-0208
Peter Snyder, MD, Principal Investigator
France
Service des Maladies, Paris, 75014, France; Recruiting
Jerome Bertherat, MD 33 (0) 1 58411895
Jerome Bertherat, MD, PhD, Principal Investigator
Italy
Clinical di Endocrinologia, Ancona, Italy; Recruiting
Marco Boscaro, MD 39 071 5964740
Marco Boscaro, MD, Principal Investigator
United Kingdom
Sir George E.Clark Metabolic Unit-Royal Victoria Hospital, Belfast,
United Kingdom; Recruiting
More Information
Study ID Numbers: CSOM230B2208
Record last reviewed: July 2004
Record first received: July 30, 2004
ClinicalTrials.gov Identifier:
NCT00088608
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on
2004-11-17
Trial Information
Summary: Cushing's Disease Study 2208
Novartis is conducting a study to assess the effectiveness and tolerability
of multiple doses of a study drug in patients with Cushing’s disease.
Patients with a confirmed diagnosis of Cushing’s disease may be eligible for
this study. Patients will self-administer the study drug via injections twice
daily for 15 days. If after 15 days the investigator finds the treatment is
providing benefit to the patients, they will be allowed to continue therapy.
Patients may chose to stop therapy at any time.
Patients must meet all of the following criteria:
- Male or female patients 18 years or older
- Patients with Cushing’s disease which has been confirmed by a Doctor’s
diagnosis and lab test results
- Ability to complete at least 15 days of study drug treatment
- Female patients must not be pregnant and must agree to use acceptable forms
of birth control throughout the course of the study, and for one month after
the study has ended
Patients will be excluded from the study for any of the following reasons:
- Have Cushing’s syndrome due to ectopic ACTH secretion
- Patients with hypercortisolism secondary to adrenal tumors or Nodular (
primary) bilateral adrenal hyperplasia
- Patients who have a known inherited syndrome as the cause for hormone over
secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
- Patient with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
- Patients who have thyroid malfunction
- Patients with the presence of active or suspected, acute or chronic,
uncontrolled infection
- Patients who have undergone major surgery one month before starting the
study
- Poorly controlled diabetes
- Patients who have cardiovascular problems (i.e. congestive heart failure,
unstable angina, etc.),
- Patients with liver disease
- History of immuno-compromise, including a positive HIV test result.
- Patients with active gall bladder disease
- Patients with active malignant disease (with the exception of basal cell
carcinoma)
For additional information about this trial click
here.
Contact:
Helen Peachey, Study Coordinator
U Penn
778 Clinical Research Building
415 Curie Boulevard
Philadelphia, PA 19104-6149
Telephone: 215-898-5664
Fax: 215-614-0418
Email: peacheyh@mail.med.upenn.edu
|
|
If you would like to learn more about participating in this study, please
send an e-mail message using the form below.
Please note: A number of commercial online services display an error message
after you click on Send. Please be assured that your message has been received.
This site is run by CenterWatch, a publishing company that focuses on the
clinical trials industry. The information provided in this service is designed
to help patients find clinical trials that may be of interest to them, and to
help patients contact the centers conducting the research. CenterWatch is
neither promoting this research nor involved in conducting any of these trials.
 We welcome your articles, letters to the editor, bios and
Cushing's information. Submit a Story or Article to
either the snailmail CUSH Newsletter or to an upcoming email
newsletter at
http://www.cushings-help.com/newsletter_story.htm
| Newest Bios: | | To add or edit your bio, please click here. | |
Bonnietta |
Bonnietta has been diagnosed and is now awaiting
treatment |
Surrey, England | |
Janice E |
Janice (pronounced JaNeece) is not yet
diagnosed |
Broadway, N.C. | |
Kim V |
Kim had pituitary surgery at NIH and is now
considering a BLA |
Hot Springs, Arkansas | |
Samara |
Samara will be having pit surgery on December
7th, 2004 |
| |
Sandie R |
Sandie has updated her bio and added pictures |
Devon, England |
• If you've been diagnosed with Cushing's, please
participate in the
Cushing's Register »
The information you provide will be used to create a register
and will be shared with the medical world. It would not be used
for other purposes without your expressed permission. Note:
This information will not be sold or shared with other
companies.
Lynne Clemens, Secretary of
CUSH Org is be the
person responsible for the creation of this register. If you
have any questions you may contact her at
lynnecush@comcast.net. You
do not have to be a member of CUSH to fill out this
questionnaire, as long as you are a Cushing’s patient. We do not
believe that the world has an accurate accounting of Cushing’s
patients. The only way to authenticate accuracy is with actual
numbers. Your help will be appreciated. Thank you." |
