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A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra
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A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

Mar 26, 2015

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Page 1: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

A novel non-estrogenic HRT in postmenopausal women with diabetes:

DHEA supplementation

Bharti Kalra, Sanjay Kalra

Page 2: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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

Page 3: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

ACTH cortical androgen stimulating hormone (CASH)

POMC derivatives

joining peptide

prolactin

IGF- 1cortisol DHEA

androstenedione age & gender

related changes

DHEA S

no diurnal variation

Page 4: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

AGE RELATED CHANGES

Foetus birth

Puberty peak old ageAdrenarche 20-30gadrenopause

250 to 500 μ g/dl

25 μ g/dl

Page 5: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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.

Page 6: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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.

Page 7: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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.

Page 8: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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

Page 9: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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

Page 10: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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

()

Page 11: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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

Page 12: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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

Page 13: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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%)

Page 14: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

SIGNIFICANT CORRELATES

0

10

20

30

40

50

60

70

80

90

100

age senN motN alb CRF thyr poorcontr

asthenia

AADS

Page 15: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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%)

Page 16: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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.

Page 17: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

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.

Page 18: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

CONCLUSION

Adrenal androgen deficiency

(dehydroepiandrosterone sulfate [DHEAS]

deficiency) is a common cause of asthenia

(42 %) in postmenopausal women with

diabetes

Page 19: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

CONCLUSION

DHEA supplementation is effective in

89.33%; and very effective in 76% of

women with documented low or below

average DHEAS.

Page 20: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

CONCLUSION

DHEA supplementation is well tolerated by

postmenopausal women with diabetes. It

is not associated with the side effects of

estrogen therapy.

Page 21: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

Sunsets are beautiful: our postmenopausal patients need not suffer unnecessarily

Page 22: A novel non-estrogenic HRT in postmenopausal women with diabetes: DHEA supplementation Bharti Kalra, Sanjay Kalra.

Thank you