The effect of testosterone and a nutritional supplement on hospital admissions in under-nourished, older people.

Phase 4

Completed

• Conditions: Acute Hospitalization; Quality of Life Years; Body Composition; Frailty Score; Nutrition Score; Strength in under-nourished, older people.; Diet and Nutrition - Obesity; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12610000356066
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-04
• Study Completion: 2015-06-30
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1.Men and women aged 65 years or older who are under-nourished, as defined by
Mini Nutritional Assessment (MNA) score 17-23.5 out of 30.
AND 1 or more of
A body mass index (BMI) of less than 22 kg/m2
Weight loss in the 3 months before enrolling in the study
2.Living independently in the community (not in a hospital, nursing home or hostel)
3.Understand and sign the informed consent document, able to communicate with the investigator, and understand and comply with the requirements of the study.
4.Women who are taking oestrogen or other hormone replacement therapy (HRT) may take part, as may women who are not taking HRT. If a woman is taking HRT she must have been on a stable dose for at least 3 months before enrolment in the study. If not on HRT, she must not have been taking it for at least 3 months before enrolment.

Exclusion Criteria

1.Elevated haematocrit (HCT) levels (>50%)
2.Past or present history of prostatic cancer in men (Prostate Specific Antigen (PSA) levels [> age-related normal range and/or irregular prostate on prostate examination])
3.Men with a past/present or family history of male breast cancer
4.Women with a past/present history of breast cancer.
5.Pre-existing androgenic signs or symptoms in women of concern to either subject or investigator (deep voice, hirsutism, acne, androgenic hair loss).
6.Depression (Yesavage Geriatric Depression Scale (GDS) Score > 12)
7.Significant cardiac failure (New York Heart Association (NYHA) functional classification system Class III and above)
8.Abnormal liver function tests ( Alanine transaminase ALT, Gamma-glutamyltransferase GGT, bilirubin or alkaline phosphatase test ALP > 2x upper limit of normal)
9.Nephrotic syndrome; 24h urine protein > 3 grams (24h urine save performed if dipstick positive proteinuria at screening) AND/OR estimated/calculated creatinine clearance (by the equation of Baracskay and Jarkoura for ambulatory elderly subjects [Cr clearance = 4.4/serum creatinine (mmol/L) + (88-age)] < 30 ml/min AND/OR serum creatinine concentration > 0.2mmol/l.
10.Any disease, which in the opinion of the investigator is likely to lead to death within 1 year
11.Folstein’s Mini Mental State Examination [MMSE] score of < 23
12.Testosterone or other androgen therapy in the four months before starting the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Days in hospital and number of hospital admissions assessed by telephone contact with participant.[12 months following randomisation.];Quality-adjusted Life Years (QALYS).<br>The (QALY) is a measure of disease burden, including both the quality and the quantity of life lived. It is used in assessing the value for money of a medical intervention. The QALY model requires utility independent, risk neutral, and constant proportional tradeoff behaviour. The QALY is based on the number of years of life that would be added by the intervention. Each year in perfect health is assigned the value of 1.0 down to a value of 0.0 for death.[12 months following randomisation]

Secondary Outcome Measures

Name	Time	Method
utritional Health assessed by questionnaires and blood tests.[3, 6 and 12 months following randomisation.];Walk time assessed by physical activity cut-off time to walk 15 feet (based on the short version of the Minnesota Leisure Time Activity Questionnaire).[Baseline, 6 and 12 months following randomisation.];Frailty Score assessed by questionnaire Fried?s Frailty Scale.[Baseline, 6 and 12 months following randomisation.];Grip Strength assessed by hand grip dynamometer test[Baseline, 6 and 12 months following randomisation.];Fat Free Mass assessed by Bioelectrical Impedance analysis (BIA).[Baseline and 12 months following randomisation.]