Trial Outcomes & Findings for Effect of Metformin on Frailty in 12 Subjects (NCT NCT03451006)

NCT ID: NCT03451006

Last Updated: 2022-11-17

Results Overview

Frailty will be measured by the Short Physical Performance Battery (SPPB). The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). Frailty is defined as a score of \<9.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: Baseline, 12 months
• Results posted on: 2022-11-17

Participant Flow

Participant milestones

Measure	Metformin Metformin 500mg tablet by mouth, every 6 to 8 hours for one year Metformin: Oral metformin (up to 2gm) were given in divided doses	Placebo Placebo by mouth every 6 to 8 hours for one year Placebo: Oral Placebo were given in divided doses
Overall Study STARTED	4	3
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Metformin Metformin 500mg tablet by mouth, every 6 to 8 hours for one year Metformin: Oral metformin (up to 2gm) were given in divided doses	Placebo Placebo by mouth every 6 to 8 hours for one year Placebo: Oral Placebo were given in divided doses
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Metformin n=4 Participants Metformin 500mg tablet by mouth, every 6 to 8 hours for one year Metformin: Oral metformin (up to 2gm) were given in divided doses	Placebo n=3 Participants Placebo by mouth every 6 to 8 hours for one year Placebo: Oral Placebo were given in divided doses	Total n=7 Participants Total of all reporting groups
Age, Continuous	75.75 years n=4 Participants	77.33 years n=3 Participants	76.54 years n=7 Participants
Sex: Female, Male Female	2 Participants n=4 Participants	1 Participants n=3 Participants	3 Participants n=7 Participants
Sex: Female, Male Male	2 Participants n=4 Participants	2 Participants n=3 Participants	4 Participants n=7 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	3 participants n=3 Participants	7 participants n=7 Participants

PRIMARY outcome

Timeframe: Baseline, 12 months

Population: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.

Frailty will be measured by the Short Physical Performance Battery (SPPB). The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). Frailty is defined as a score of <9.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 12 months

Population: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.

This measure is part of the SPPB. The scores range from 0 (not attempted), to 2 (held for 10 seconds). Ability to stand longer in this position indicates greater balance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 12 months

Population: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.

This measure is part of the SPPB. The semi tandem position is the heel of one foot place by the big toe of the other foot. The scores range from 0 (not attempted), to 2 (held for 10 seconds). Ability to stand longer in this position indicates greater balance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 12 months

Population: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.

This measure is part of the SPPB. The full tandem position is with the feet directly in front of each other. The scores range from 0 (not attempted), to 2 (held for 10 seconds). Ability to stand longer in this position indicates greater balance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 12 months

Population: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.

This measure is part of the SPPB. Subjects will be asked to walk 8 feet or 2.44 meters at their usual pace. They will be allowed to use a cane or other walking aid if it is their custom. Scores range from 0 = could not do to 4 =<3.1 seconds.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline,12 months

Population: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.

This measure is part of the SPPB. Subjects will be asked to try to stand up from a chair 5 times with arms folded across their chest, and will be timed. Scores range from 0 to 4, with 0 = unable to stand without using arms, and 4 = completing 5 stands in <11.1 seconds.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.

Serum will be collected to measure the effect of metformin on senescent markers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.

Serum will be collected to measure the effect of metformin on senescent markers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.

Serum will be collected to measure the effect of metformin on senescent markers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.

Serum will be collected to measure the effect of metformin on senescent markers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.

Serum will be collected to measure the effect of metformin on senescent markers.

Outcome measures

Outcome data not reported

Adverse Events

Metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mandeep Singh, M.D.

Mayo Clinic

Phone: 507-255-2398

Email: Singh.Mandeep@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place