a novel non-estrogenic hrt in postmenopausal women with diabetes: dhea supplementation bharti kalra,...
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A novel non-estrogenic HRT in postmenopausal women with diabetes:
DHEA supplementation
Bharti Kalra, Sanjay Kalra
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ADRENAL ANDROGEN PHYSIOLOGY cholesterol
zona glomerulosa pregnenolone aldosterone 100 mg/d
zona fasciculata 17-OH pregnenolone cortisol 10mg/d
zona reticularis DHEA androstened- >20mg/d
4mg 1.5mg
DHEAS
7-15mg
estradiolDHT
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ACTH cortical androgen stimulating hormone (CASH)
POMC derivatives
joining peptide
prolactin
IGF- 1cortisol DHEA
androstenedione age & gender
related changes
DHEA S
no diurnal variation
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AGE RELATED CHANGES
Foetus birth
Puberty peak old ageAdrenarche 20-30gadrenopause
250 to 500 μ g/dl
25 μ g/dl
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AIMS AND OBJECTIVES
To assess the incidence of DHEAS deficiency amongst
postmenopausal diabetic women with asthenia
To assess the clinical correlates of DHEAS deficiency .
To assess the effects of DHEA supplementation on
asthenic symptoms in postmenopausal diabetic women.
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STUDY DESIGN
Prospective,open-label randomized study over 6 months
Single centre study conducted from Oct 2005 to June
2006.
354 consecutive postmenopausal diabetic women
complaining of asthenia were administered the Energy
Fatigue Scale (Stanford).
Women with positive score ( ≥ 2.20) underwent DHEAS
estimation.
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STUDY DESIGN
Women with DHEAS levels below normal or in the lower
quartile of normal range were randomized to either of 2
groups.
Study group given DHEA supplementation
25 mg /day x 6 months along with routine medication;
control given only antidiabetic drugs.
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STUDY DESIGN
Clinical and biochemical assessment was
carried out at 3 months and 6 months.
Dose of DHEA was adjusted at 3 months and 6
months according to DHEAS values.
Aim to keep DHEAS values in upper half of
normal range according to age
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RESULTS
354 postmenopausal women with diabetes with asthenia.
(diabetes 1-35 years; asthenia 1-24 months)
women with AADS (42.4%)
STUDY GROUP: 75
DHEA Supplementation
CONTROL GROUP: 75
No DHEA Supplementation
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AGE DISTRIBUTION OF PATIENTS
Age Yrs. 31-40 41-50 51-60 61-70 71-80 81-90
Study group
1
(1.3%)
27
(35.52)
32
(42.10%)
6
(7.89%)
5
(6.57%)
5
(6.57%)
Control group
0
(0%)
32
(42.10%)
26
()
10
()
4
(%)
3
()
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AVERAGE DOSE/LEVELS OF DHEA
• The average dose of DHEA required to correct DHEAS
levels was 24.31 ± 10.75 mg at 3 months and 30.40 ±
13.67 mg at 6 months.
• The average level at baseline was 40.86 ± 23.40
μg/ml in the AADS cohort. It rose to 81.39 ± 51.71 μg/ml
at 3 months and 89.53 ± 51.50 μg/ml at 6 months
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IMPROVEMENT IN ENERGY SCORE: Study group
0
2
4
6
8
10
12
changein score
3 monthsfollow up
6 monthsfollow up
No. ofsubjects
Drop-out
zero 0.2-0.8
≥ 1.0
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CLINICAL CORRELATES OF ASTHENIC PATIENTS
Frequency in Asthenic Patients
(Total=354)
DHEA-S deficient (AADS) patients
(Total =150)
Age > 60 Years* 75
(21.18%)
79
(52.67%)
Sensory neuropathy* 186
(52.54%)
142
(94.66%)
Motor neuropathy* 79
(22.31%)
63
(42.00%)
Albuminuria * 19
(5.4%)
47
(31.33%)
Chronic renal failure*
(se creat >1.5)
14
(3.9%)
24
(16.00%)
Hypothyroidism* 75
(21.18%)
71
(47.33%)
Poor glycemic control *
(HB A1c >8.0%)
158
(44.64%)
95
(63.33%)
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SIGNIFICANT CORRELATES
0
10
20
30
40
50
60
70
80
90
100
age senN motN alb CRF thyr poorcontr
asthenia
AADS
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CLINICAL CORRELATES OF ASTHENIC PATIENTS
Frequency in Asthenic Patients
(Total=354)
DHEA-S deficient (AADS) patients
(Total =150)
Hypertension 288
(81.35%)
134
(89.33%)
Coronary Heart disease 5
(1.41%)
0
(0%)
Stroke 27
(7.62%)
15
(10. 00%)
Foot Ulcer 9
(2.54%)
0
(0%)
Anemia 130
(36.72%)
71
(47.33%)
Hypoproteinemia 18
(5.08%)
8
(5.33%)
Hepatic Dysfunction 28
(7.91%)
0
(0%)
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EFFECTS
• DHEA-S levels rose significantly after supplementation with
oral DHEA .
• Most patients felt the maximum benefit of therapy within 4-6
weeks.
• 16.00% study patients and 4.00% controls reported a
subjective improvement in libido.
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SIDE EFFECTS
• One patient each complained of excessive perspiration,
itching, and ‘increased anger’, but there was no drop out.
Symptoms were self-limiting in all patients.
• DHEA-S therapy is not associated with the side effects
of estrogen therapy.
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CONCLUSION
Adrenal androgen deficiency
(dehydroepiandrosterone sulfate [DHEAS]
deficiency) is a common cause of asthenia
(42 %) in postmenopausal women with
diabetes
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CONCLUSION
DHEA supplementation is effective in
89.33%; and very effective in 76% of
women with documented low or below
average DHEAS.
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CONCLUSION
DHEA supplementation is well tolerated by
postmenopausal women with diabetes. It
is not associated with the side effects of
estrogen therapy.
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Sunsets are beautiful: our postmenopausal patients need not suffer unnecessarily
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Thank you