Trial Outcomes & Findings for Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C) (NCT NCT02865499)
NCT ID: NCT02865499
Last Updated: 2019-03-14
Results Overview
Changes in bacterial community measurement through DNA extraction from stool samples. Change is measured using operational taxonomic units (OTU). An OTU is the group of organisms being studied through DNA to cluster sequences of microbiomes according to their similarity to one another (the similarity threshold is set to 97%). This outcome measures change in the number of OTUs from baseline to 12 weeks.
COMPLETED
PHASE2
8 participants
Baseline; 8 weeks and 12 weeks
2019-03-14
Participant Flow
Participant milestones
| Measure |
Acarbose
all participants will receive acarbose
acarbose: acarbose treatment with meals
|
|---|---|
|
Baseline
STARTED
|
8
|
|
Baseline
COMPLETED
|
6
|
|
Baseline
NOT COMPLETED
|
2
|
|
8 Weeks
STARTED
|
6
|
|
8 Weeks
COMPLETED
|
6
|
|
8 Weeks
NOT COMPLETED
|
0
|
|
12 Weeks
STARTED
|
6
|
|
12 Weeks
COMPLETED
|
6
|
|
12 Weeks
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Acarbose
all participants will receive acarbose
acarbose: acarbose treatment with meals
|
|---|---|
|
Baseline
Adverse Event
|
1
|
|
Baseline
Withdrawal by Subject
|
1
|
Baseline Characteristics
Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C)
Baseline characteristics by cohort
| Measure |
Acarbose
n=6 Participants
all participants to receive acarbose
acarbose: acarbose treatment with meals
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline; 8 weeks and 12 weeksChanges in bacterial community measurement through DNA extraction from stool samples. Change is measured using operational taxonomic units (OTU). An OTU is the group of organisms being studied through DNA to cluster sequences of microbiomes according to their similarity to one another (the similarity threshold is set to 97%). This outcome measures change in the number of OTUs from baseline to 12 weeks.
Outcome measures
| Measure |
Acarbose
n=6 Participants
Stool specimens from all participants analyzed after acarbose
|
|---|---|
|
Change in Microbiome
Baseline Measurement
|
0 Operational Taxonomic Unit (OTU)
|
|
Change in Microbiome
8 Week Measurement
|
0 Operational Taxonomic Unit (OTU)
|
|
Change in Microbiome
12 Week Measurment
|
0 Operational Taxonomic Unit (OTU)
|
Adverse Events
Acarbose
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dean L. Kellogg, Jr, MD, PhD
Univ TX Health Science Center San Antonio
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place