Trial Outcomes & Findings for SGLT2 Inhibition in Older Obese Adults With Pre-diabetes (NCT NCT04401904)
NCT ID: NCT04401904
Last Updated: 2024-01-05
Results Overview
Change in AGE-RAGE measured by enzyme-linked immunosorbent assay (ELISA).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2024-01-05
Participant Flow
Participant milestones
| Measure |
Dapagliflozin
10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.
Dapagliflozin 10 mg: 10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth
|
Nutritional Counseling
10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks
Nutritional counseling: 10 participants randomized to receive 12 weeks of weekly counseling on nutrition
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SGLT2 Inhibition in Older Obese Adults With Pre-diabetes
Baseline characteristics by cohort
| Measure |
Dapagliflozin
n=10 Participants
10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.
Dapagliflozin 10 mg: 10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth
|
Nutritional Counseling
n=10 Participants
10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks
Nutritional counseling: 10 participants randomized to receive 12 weeks of weekly counseling on nutrition
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=39 Participants
|
10 participants
n=41 Participants
|
20 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksChange in AGE-RAGE measured by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Dapagliflozin
n=10 Participants
10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.
Dapagliflozin 10 mg: 10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth
|
Nutritional Counseling
n=10 Participants
10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks
Nutritional counseling: 10 participants randomized to receive 12 weeks of weekly counseling on nutrition
|
|---|---|---|
|
AGE-RAGE Measurement in Plasma
|
-172 pg/mL
Standard Error 121
|
-86 pg/mL
Standard Error 112
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange in grip strength measured using a hand-held dynamometer in Newton meters (Nm)
Outcome measures
| Measure |
Dapagliflozin
n=10 Participants
10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.
Dapagliflozin 10 mg: 10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth
|
Nutritional Counseling
n=10 Participants
10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks
Nutritional counseling: 10 participants randomized to receive 12 weeks of weekly counseling on nutrition
|
|---|---|---|
|
Grip Strength
|
-2 Nm
Standard Error 1.3
|
-1 Nm
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange in walking distance in the 6 minute walking test.
Outcome measures
| Measure |
Dapagliflozin
n=10 Participants
10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.
Dapagliflozin 10 mg: 10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth
|
Nutritional Counseling
n=10 Participants
10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks
Nutritional counseling: 10 participants randomized to receive 12 weeks of weekly counseling on nutrition
|
|---|---|---|
|
6 Minute Walking Distance
|
6.6 m
Standard Error 7.6
|
9.1 m
Standard Error 11.8
|
Adverse Events
Dapagliflozin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nutritional Counseling
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place