Aging, Diabetes Mellitus, Type 2, PreDiabetes, Overweight and Obesity
Conditions
Brief summary
Semaglutide is a medication approved by the US Food and Drug Administration (FDA) as an antihyperglycemic (a drug that reduces glucoses in those with diabetes) and for weight management. This new study will help find out what effects, semaglutide has on people who take the drug and the drug's effect on physical function, body composition, and aging.
Interventions
Semaglutide will be started at 0.25mg once a week for 4 weeks followed by 0.5mg once weekly for 4 weeks followed by 1.0mg once a week for 12 weeks.
BEHAVIORALLifestyle Counseling
Lifestyle Counseling will be provided throughout study intervention
Sponsors
National Institute on Aging (NIA)
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Older than 65 * Have prediabetes or diabetes * BMI ≥ 27.0 kg/m2 * Living independently (not in assisted living or nursing home)
Exclusion criteria
* Have heart disease * Have liver disease * Smoke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lean Body Mass Change | Baseline to 20 weeks | Determine if there is any change in lean body mass |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide and Lifestyle Intervention Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program. They will also be given semaglutide for 20 weeks.
Semaglutide Injectable Product: Semaglutide will be started at 0.25mg once a week for 4 weeks followed by 0.5mg once weekly for 4 weeks followed by 1.0mg once a week for 12 weeks.
Lifestyle Counseling: Lifestyle Counseling will be provided throughout study intervention | 10 |
| Lifestyle Intervention Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program
Lifestyle Counseling: Lifestyle Counseling will be provided throughout study intervention | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Semaglutide and Lifestyle Intervention | Lifestyle Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 71.9 years STANDARD_DEVIATION 4.85 | 73.4 years STANDARD_DEVIATION 4.98 | 72.65 years STANDARD_DEVIATION 4.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 6 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Lean Body Mass Change
Determine if there is any change in lean body mass
Time frame: Baseline to 20 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Semaglutide and Lifestyle Intervention | Lean Body Mass Change | -1730.6 g |
| Lifestyle Intervention | Lean Body Mass Change | -421 g |