Trial Outcomes & Findings for Ghrelin in Healthy and Frail Older Women (NCT NCT00520884)

Results Overview

Kilocalorie consumption from meal of standardized composition during the visit when infusion complete

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

After infusion

Results posted on

2019-06-13

Participant Flow

Seventeen women were screened. Ten qualified - five had unintentional weight loss of \>5% in the prior year plus at least 2 out of the 4 remaining Fried criteria for frailty and five healthy women without any frailty criteria. Women with conditions that can cause weight loss or taking an appetite stimulant or corticosteroids were excluded.

Participant milestones

Participant milestones
Measure	Healthy Participants, Ghrelin First, Then Saline Healthy participants, ghrelin first, then saline	Healthy Participants, Saline First, Then Ghrelin Healthy participants, saline first, then ghrelin	Frail Participants, Ghrelin First, Then Saline Frail participants, ghrelin first, then saline	Frail Participants, Saline First, Then Ghrelin Frail participants, saline first, then ghrelin
Overall Study STARTED	3	2	2	3
Overall Study COMPLETED	3	2	2	3
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ghrelin in Healthy and Frail Older Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy n=5 Participants Receiving Placebo at one visit/Ghrelin at other visit	Frail n=5 Participants Receiving Placebo at one visit/Ghrelin at other visit	Total n=10 Participants Total of all reporting groups
Age, Continuous	80.6 years n=93 Participants	80.0 years n=4 Participants	80.3 years n=27 Participants
Sex/Gender, Customized	5 participants n=93 Participants	5 participants n=4 Participants	10 participants n=27 Participants

PRIMARY outcome

Timeframe: After infusion

Population: Per protocol, primary analysis combined healthy and frail groups. The study was not powered to make statistical comparisons between the healthy and frail groups. Therefore, we are providing combined data per our protocol.

Kilocalorie consumption from meal of standardized composition during the visit when infusion complete

Outcome measures

Outcome measures
Measure	Saline Infusion n=10 Participants Saline infusion in combined healthy and frail groups	Ghrelin Infusion n=10 Participants Saline infusion in combined healthy and frail groups
Kilocalories Consumed	412 Kilocalorie Standard Deviation 151	553 Kilocalorie Standard Deviation 151

PRIMARY outcome

Timeframe: 180 minutes

Population: Per protocol, primary analysis combined healthy and frail groups. The study was not powered to make statistical comparisons between the healthy and frail groups. Therefore, we are providing combined data per our protocol.

Maximum growth hormone level change from baseline to 180 minutes

Outcome measures

Outcome measures
Measure	Saline Infusion n=10 Participants Saline infusion in combined healthy and frail groups	Ghrelin Infusion n=10 Participants Saline infusion in combined healthy and frail groups
Max Change Growth Hormone	0.33 ng/mL Standard Deviation 1.44	14.24 ng/mL Standard Deviation 8.49

PRIMARY outcome

Timeframe: 180 minutes

Population: Per protocol, primary analysis combined healthy and frail groups. The study was not powered to make statistical comparisons between the healthy and frail groups. Therefore, we are providing combined data per our protocol.

Maximum total ghrelin change from baseline to 180 minutes

Outcome measures

Outcome measures
Measure	Saline Infusion n=10 Participants Saline infusion in combined healthy and frail groups	Ghrelin Infusion n=10 Participants Saline infusion in combined healthy and frail groups
Max Change Total Ghrelin	-68.6 pg/mL Standard Deviation 90.6	1803.2 pg/mL Standard Deviation 714.8

PRIMARY outcome

Timeframe: 180 minutes

Population: Per protocol, primary analysis combined healthy and frail groups. The study was not powered to make statistical comparisons between the healthy and frail groups. Therefore, we are providing combined data per our protocol.

Active ghrelin change from baseline to 180 minutes. Active ghrelin=acylated ghrelin.

Outcome measures

Outcome measures
Measure	Saline Infusion n=10 Participants Saline infusion in combined healthy and frail groups	Ghrelin Infusion n=10 Participants Saline infusion in combined healthy and frail groups
Max Change Active Ghrelin	-9.1 pg/mL Standard Deviation 20.4	845.4 pg/mL Standard Deviation 448.3

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ghrelin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=10 participants at risk Healthy and frail participants had a study visit in which they received placebo (saline) infusion	Ghrelin n=10 participants at risk Healthy and frail participants had a study visit in which they received ghrelin infusion
General disorders sensation of warmth	0.00% 0/10 • 1 week after each infusion	40.0% 4/10 • Number of events 4 • 1 week after each infusion

Additional Information

Anne Cappola, M.D., Sc.M.

University of Pennsylvania, Department of Medicine, Division of Endocrinology, Diabetes and Metabolism

Phone: 215-573-5359

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place