NATIONAL FEATURED ARTICLE
for MEN with DIABETES
Edward Lichten, M.D.,
Historical Perspective: In the First World War, there is an unsubstantiated report that the testicles from a dead soldier were transplanted into the abdominal wall of a man with gangrene. The story goes that the man recovered and did not need amputation. This story would be considered whimsical if it were not for the work of Jens Moller, M.D1. in Denmark from 1950 to 1984. Moller and 250 other European physicians used injections of bio-identical testosterone to treat diabetes, gangrene and related heart disease in more than 10,000 men and women. Moller’s enthusiasm overshadowed the observation that the dosages of testosterone used significantly increased the incidence of heart disease in treated women. This led to his public humiliation, a disbanding of the European physicians, and a misconception that testosterone was dangerous.
Personal Experience: When Dr. Lichten turned 45 years of age, he crashed. It seemed like overnight he went from being an enthusiastic, hard working, physically potent man to be a depressed, lethargic, exhausted old man. His symptoms included night sweats so extreme that he had to take two showers every night. His colleagues had no idea what to do—one offered to admit him to the hospital to get an answer. But as a physician, he knew the hospital offered no answers. Rather, the discovery of the cause of his malaise came from the unbiased information offered from his older gynecology patients. Two women told the doctor that their 70 year-old husbands had the same symptoms. So, Dr. Lichten ran his menopausal laboratory tests on his own blood. Lucky! Doctor Lichten was one of the first recognized ‘menopausal’ males. With this newfound information, he asked his urologist about testosterone replacement. He told him that no one believed in testosterone for men, it was too dangerous, and the laboratory tests could be best explained by the large number of menopausal women being treating in his practice--they had influenced his tests!
So, Dr. Lichten searched out the literature, found a doctor who believed in testosterone replacement, and started testosterone replacement under physician supervision in 1995. And his life has never been sweeter since he began ‘drinking from man's bio-identical fountain of youth.’
The pictures show the dramatic changes in physical appearance. At 42, tired, wrinkled and full faced—at almost 51, muscular, lean and a renewed enthusiasm radiating from a healthy body and face! His women patients noticed the difference, and since low dose testosterone replacement has been a mainstay of Dr. Lichten’s treatment of menopausal women, they were intrigued. After questioning, they asked if Dr. Lichten would treat their husbands: not only because of their husband's erection dysfunction and lack of libido, but because they worried that their husbands’ health was being jeopardized. He agreed and the third man treated was a 295 pound, five foot 10 inch male with adult onset diabetes.
Joe at 48 confided that he was worried about seeing his daughter grow up. Once an active man, he now could not walk up a flight of stairs without becoming short of breath. He knew being diabetic affected his heart as severely as having a heart attack, and he could not lose weight although he tried. After performing a glucose tolerance test with matching insulin levels, Dr. Lichten determined Joe to be an early vs. burned-out diabetic. So testosterone injections weekly were begun and his blood sugars, watched. Joe’s finger-sticks of glucose dropped the first week into the normal range. He felt better and was able to walk up the stairs without difficulty. He lost 20 pounds the first month, allegedly without trying. The second month he joined a gym and lost another 20 pounds. Then after the third month, he had lost another 10. And at the one-year testosterone-replacement anniversary, Joe weighed in at 215 pounds—80 pounds lighter. And at 18 months, his repeat glucose tolerance test and matching insulin and testosterone hormonal parameters were normal. Able to run on the treadmill for 90 minutes, Joe was, at that point in time, clinically not diabetic. And his wife had returned to Dr. Lichten’s office for her every two-week testosterone injection. It seems that the libido enhancing bio-identical hormonal replacement program with testosterone had proved to be so much more effective than Viagra® as a first choice of treatment (and the literature agrees2).
In the hospital, a 59-year old insulin dependent diabetic was scheduled for amputation of his finger. The infection had begun with the repeated glucose testing lancets and had eaten away the tissue to the bone. In the hospital he was listless, unshaven, not eating and displaying the ominous Q-sign: his tongue was hanging out of the side of his mouth. As a family friend Dr. Lichten was beseeched to do something: He offered an injection of short-acting testosterone. The hospital was in an uproar as this was considered unapproved therapy for men let alone diabetes. Yet, his diabetic patient’s blood sugars dropped 50 points in the first day, he got out of bed, shaved and ate his meals. With two more injections that week, his finger started to heal so the amputation was cancelled and he felt well enough to not only go home but make ‘900’ number calls from the hospital (you should get my gist now). At home, his wife forbade any more testosterone injections as she stated his erections had returned after a two-year hiatus. When he died four years later of cardiac disease, he died with his finger healed and intact.
With the incidence of diabetes approaching 25% of the general population over 60, the development of 'adult onset' or nutritional diabetes in younger and younger pre-teens and teenagers, and its racial predilection for dark skinned individuals, it is estimated that 1 in 3 children born in the United States today will become diabetic.11 Diabetes is more than an epidemic-- it is a pandemic of unbelievable proportions.
IN 2004, the Estimated direct and indirect costs of diabetes in the United States were $120 billion dollars. Estimated costs of diabetes are expected to double by the year 2010. Diabetes is the number health care cost-- and all efforts to control this disease, all the billions of dollars sent in research, have failed miserably.11
Armed with this information Dr. Lichten approached his colleague, James Sowers, M.D., professor and chairman at Wayne State University in Detroit, Michigan. Dr. James Sowers is considered one of the foremost diabetic experts in the United States. Intrigued by Dr. Lichten’s observations, they devised a pilot study for up to 100 diabetic men. After base-line laboratory studies of their bio-identical sex hormones (testosterone, estradiol, sex hormone binding globulin), general lab testing, Prostate Specific Antigen (PSA), and a two-hour glucose test with insulin the volunteer diabetic men would be treated with monthly testosterone implants. The patients would be seen monthly for three months on testosterone and then for four months off testosterone injections. Testing occurred at regular, one-month intervals.
The problem with standard medical care is that the physician rarely performs a glucose tolerance test and almost never performs the corresponding insulin measurements. While a normal glucose tolerance and insulin response appear in the table below, any deviation from this is scientific evidence of metabolic syndrome, pre-diabetes and/or insulin resistance. The terminology is irrelevant. What differentiates these states from true diabetes is that the percentage of stored glucose (glycogen) in the red cell is greater than 6%. This single test is the only definitive test for diabetes: it is called glycogenated hemoglobin or hemoglobin A1c (Hgb-A1c).
To simplify the diagnosis of normal versus early or insulin requiring Adult Onset Diabetes Mellitus, Dr. Lichten suggest adding up the 0, 1 and 2-hour insulin values. He calls this SumI. The mathematical formula would look like this: ∑ I= I0+ I1+ I2
In the 1997-1999 pilot-study approximately 75 adult men with diabetes volunteered for treatment. Fifteen men were already on insulin. Ten of them were considered brittle diabetics as they used 80 to 120 units of insulin per day and were prone to have precipitous drops in blood sugar called hypoglycemia. Because a hypoglycemic attack can result in coma and death, few doctors closely titrate these individuals to achieve a preferred, 6% Hgb-A1c, because of these risks.
The initial evaluation showed every man who was diabetic3 was low in testosterone. [Ten years later, EL Ding4 at Harvard would come to the same conclusion]. The laboratory measurements relied not only on the absolute number of total testosterone (normal 251-1000 ng/dl) but to the bio-available measurement of testosterone. Bio-available means how much is available in the circulation and can be used. Based on the pioneering work of D.C. Anderson5 in 1972 published in both Science and Nature, the ‘free’ or 'unbound' testosterone is the ratio of the concentration of total testosterone divided by the concentration of sex hormone binding globulin. Anderson calls this the Free Androgen Index (FAI). The mathematical formula is: [.3nmol/ng] [total testosterone ng/dl] /[sex hormone binding globulin nmol/liter]. Note the 0.3 is the conversion factor for the different measurements. Only 'unbound' or ‘free’ testosterone is biologically active.
Anderson showed that a young teenager or adult would have a Free Androgen Index (FAI) of 1.0 and a normal male would remain above 0.7 into his 60’s. All the diabetic men had a FAI of less than 0.4 and those experiencing a worsening of the disease (such as insulin requiring) had lower FAIs, actually closer to 0.3. As Dr. Lichten continued his study and measured diabetic men on dialysis, the ratio dropped further to less than 0.2.
Having no preconceived expectation, the study followed the insulin requiring adult diabetics for 3 months. Most reduced their insulin requirements by half without changing their hemoglobin A1c. Men on 120 units now needed 60 units; men on 80 units need 40. But the next observation may be destined to change the medical practice of diabetes forever:
THESE MEN ON TESTOSTERONE INJECTIONS,
When Charles came into the office, Dr. Lichten was surprised to see his finger-stick glucose at 37mg/ml. When questioned, he told Dr. Lichten that his internist had called him the night before alarmed at the same low reading from his blood sample sent to the national laboratory. Charles had no symptoms and he knew the symptoms of hypoglycemia and impending coma. He was instructed to reduce his insulin by another 10 units per day. And he agreed to do so. But why didn’t he crash?
The medical literature including Tibbins6 reported testosterone sensitizes the cell in men to more readily admit glucose. This is termed a decrease in insulin resistance. Therefore, whatever insulin is available, it works much more efficiently in the presence of testosterone in men. Of note, estradiol, the female hormone, works contra-productively for the male, and worsens insulin resistance.
Dr.Lichten’s continuing studies can explain why men on testosterone have much less worry about hypoglycemia and diabetic coma. It is obvious that the second role of testosterone is to accelerate not only the conversion of glucose in the blood stream to stored cellular glycogen but also to reverse the process when needed: testosterone accelerates the conversion of stored tissue glycogen to serum glucose. That is the explanation for why diabetic males on testosterone injections are much better protected from hypoglycemic related coma and death. And with this unique effect of testosterone, tighter control is not only desired, it can be more easily achieved. Dr. Lichten routinely has lowered insulin requiring diabetic men from a Hgb-A1c of 8, 9, 10 and 11% to between 6 and 7%. Morbidity, mortality and costs of tighter control statistically may be reduced as much as 75%! Dr. Lichten expects fewer heart attacks, fewer strokes, fewer attacks of blindness and fewer men tethered to dialysis. Diabetic men can and should live longer and live better!
And then to Dr. Lichten’s office, came Anthony a 50-year old African-American male without insurance, employment, or regular meals, let alone medication. His fasting glucose was 488mg/ml and his Hgb-A1c was greater than 18! (Hgb-A1c of 6 is normal). Dr. Lichten immediately treated Anthony with twice the standard dose of testosterone and followed his blood sugars daily. Over the next four months he titrated Anthony’s long-acting insulin from 20 units per day to 90 units and continued a sliding scale of regular insulin at approximately 20 units per day with meals.
What was never expected was the rapidity with which Anthony’s intracellular glycogen stores would normalize. His Hgb-A1c dropped in four weeks from 18 to 15.7%; at 3 months it was 11% and at 5 months 7.4%!! The Journal of the American Medical Association7 reported that in the best of circumstances only 40% of insulin dependent men could be stabilized at a hemoglobin A1c of 8% or less. And here was Dr. Lichten driving the worst diabetic from 18 to 7.4 Hgb-A1c. And the treatment hadn’t stabilized yet!
Anthony had memory lapses originating from the high glucose in his blood stream and his brain tissue. This is not unusual for uncontrolled diabetics. One evening he injected 30 units of regular, short acting insulin instead of his long-acting insulin. On a evening call to Dr. Lichten, Dr. Lichten had him eat his dinner and check his glucose levels every two hours. His glucose testing never showed a value below 129 mg/ml! Another time, he awoke at 4 A.M. and took his regular insulin and went back to bed without eating. His morning glucose was in the 80-90 mg/ml range. No crash, no coma, no severe symptoms!
And as noted in the table above, no matter how much testosterone was given to Anthony, his total testosterone never exceeded the upper limits of normal for men (1000-1200ng/dl). He never developed polycythemia, which is a high red cell count. This is the only real complication of continuous testosterone injections. And the solution for testosterone taking patients and for Dr. Lichten himself is to donate blood at the Red Cross every 4 months. Simple.
Conclusions: For insulin requiring diabetic men without contra-indications, add back testosterone as injections and follow their improved glycemic control and reduce their insulin requirements accordingly. Not only will the improved glycemic control reduce morbidity, but the positive effects of testosterone replacement on the heart, memory, bone and red-cell producing cells will reduce the risk of heart attack, Alzheimer’s disease, osteoporosis and the need for Epogen® in dialysis patients. In documented cases, the dose of Epogen® was reduced by 50% in men with diabetes on dialysis.8
And for the adult onset diabetic men on diet and oral agents, the results were similarly outstanding. Now, this group of less than 50 men consisted of two groups. The two-hour glucose tolerance test with insulin showed two-thirds of them to be ‘early’ diabetics with a hyper-secretion of insulin and low testosterone. With replacement of the testosterone to normal physiologic levels and a normalization of the FAI, many of these men were able to discontinue their use of oral hypoglycemic agents and show improvement in their Hgb-A1c. For those that could not reach the Hgb-A1c of 6, we restarted the most inexpensive generic hypoglycemic agents. And these men on testosterone uniformly were pleased with their reawakened vim and vigor, loss of inches from their waists and improved workout performance.
But for the remaining adult onset diabetic men on oral agents, their personal physicians had not realized they were in fact ‘burned-out.” The insulin part of the Glucose Tolerance Test (GTT-I) showed no four-fold increase in insulin value at 1 or 2 hours: rather, the numbers were flat and relatively unchanged. Therefore, these men, fully one-third of adult men on oral agents, were taking expensive medications that were in fact, worthless. Some of these men were able to achieve better control on testosterone alone. And a few, in time would develop a need for insulin.
Dr. Lichten’s goal remains the same as everyone who treats diabetes: a hemoglobin A1c of 6.0. And in our office, with time and co-operation from our patients, almost all men are stabilized with a hemoglobin A1c of 6 and 7. Glucose levels below 110 mg/ml are commonplace!
Just last year, D. Kapoor9 in England published a study of 20 diabetic men reporting improvement in glycogenated hemoglobin (Hgb-A1c), waist circumference, lipids, performance and other parameters as we had mentioned previously. Kapoor's dosing was 200mg testosterone cyprionate intramuscularly every two weeks. So, the neigh sayers should be ever so humble. Testosterone is a necessary treatment for diabetic men, even more so than insulin! Because insulin is applicable to 10% of the male population with diabetes but testosterone should be useful to almost 100%. Simple, effective, cheap, safe and life-saving testosterone. Testosterone is truly man’s best adjunct for a long and healthy life, diabetic or not.
Complications and Risks:
Rather, Morganteler10 showed that testosterone may be protective against prostate cancer. In a large study of men with low levels of testosterone and normal prostate specific antigen (PSA <2; PSA 2-4), a full 15-30% had biopsy proven prostate cancer. The incidence was almost twice as high for men with total testosterone levels less than 250 ng/dl. Imagine, not having adequate testosterone levels not only predicts a higher incidence of diabetes, heart disease, osteoporosis, Alzheimer’s disease but also prostate cancer!
So, from a medical and health perspective, every doctor should get the appropriate laboratory tests performed on every male over 35 years of age and especially those with suspected health issues. For those who prefer to be tested prior to visiting their physician about testosterone replacement, laboratory tests can be ordered through Dr. Lichten’s website: http://www.USDOCTOR.com and drawn at any Quest Diagnostics station. This way, all laboratory tests are made available to the individual and Dr. Lichten who has assembled a team of diabetic experts to be available to review the findings as part of an Internet-based, video, audio or written consultation service. For those who wish to further understand the meaning of the laboratory tests, Dr. Lichten has included an in-depth explanation of these tests within his book entitled, “AGELESS for MEN: Living without Diabetes, Heart Disease and Viagra," which can be downloaded from the INTERNET.
Comments: Thousands of years ago, man recognized that castration took away a man’s manhood both physically and emotionally. In our environment, the use of hormone implants in our food stock, the use of xeno-estrogen plastics and pesticides is responsible for the dramatic drop in bio-available testosterone and sperm counts in American men over the last 50 years. In this same time period, the incidence of diabetes and heart disease has increased more than 600%. Without simple, effective cheap testosterone injections, not gels that aromatize into estrogen, we will be faced by more disease in a younger and younger population.
All men must accept the fact that TESTOSTERONE is their NATURAL, BIO-IDENTICAL LIFE HORMONE or face premature death and disease unaided by nature’s protector. Say ‘YES to TESTOSTERONE’ and we might hold the diseases of diabetes, heart disease, osteoporosis, Alzheimer’s disease and even prostate cancer in abeyance a little longer.
Edward M. Lichten, M.D.,
Textbook of Bio-identical Hormones
Diabetic and Interested Patients
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Drugs Delegated to Secondary
.Drugs Delegated to Tertiary Status
Joe at 295 pounds
Joe after 1 year of testosterone therapy