Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05302596 |
| Other study ID # |
STUDY00005760 |
| Secondary ID |
UL1TR001412 |
| Status |
Active, not recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
June 15, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
State University of New York at Buffalo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a single-center, prospective, controlled, randomized and open label study to
investigate the effect of the semaglutide addition to standard of care weight loss
intervention (personalized lifestyle and exercise) in elderly obese subjects on body weight
and body composition as assessed by DEXA.
Description:
This will be a single center, prospective, open label, randomized and controlled pilot study
to investigate the effects of semaglutide addition to a standard weight loss intervention
program for 16 weeks on body weight and composition, adipose tissue metabolism and muscle
strength compared to the standard weight loss program alone in elderly obese patients.
Eligible and qualified patients will be randomized 1:1 in pairs (8 pairs) matched by age and
BMI within 5% and by gender to one of two open-label interventions. Priority of enrollment
will be to match already existing and non-matched pair(s) before starting new ones. However,
participants will not need to wait until they are matched to be enrolled in the study. The
two open-label interventions are:
1. Control group: Standard of care weight loss program that includes lifestyle changes and
personalized exercise and dietary education.
2. Semaglutide group: semaglutide (up to 1mg) once weekly injection added to the standard
of care weight loss program. Semaglutide dose will be started at 0.25 mg dose during the
baseline visit and doubled every 2 weeks up to 1mg dose or up to maximum tolerable dose.
Patients will be instructed on how to inject themselves with the drug and how to
increase the dose. During dose escalation, we will be monitoring the subject more
extensively (4 weeks and 8 weeks), compared to clinical practice, for any side effects
including if they experience any GI side effects, and subjects will be kept at the
maximum tolerable dose up to 1mg/week.
At the baseline visit, and for all other visits, patients will come fasting (10 -12 hours) to
the research center. Patients will visit the research center at 4 weeks (safety visit), 8
weeks and at 16 weeks (final study assessment visit). Blood (about 25 ml), body weight and
other vitals, adverse events including hypoglycemia (blood sugar <70 mg/dl) will be collected
at all visits. Fat biopsy aspiration, DEXA scans, muscle strength measurement and
age-appropriate quality of life questionnaire (Quality of Life Enjoyment and Satisfaction
Questionnaire - Short Form (Q-LES-Q-SF) will be performed at 0- and 16-weeks visits.
All patients will receive instructions at the beginning of the study on weight loss
nutritional program and appropriate physical activity to be performed for the next 16 weeks.
The program will be based, in-part, on dietary and exercise habits collected at screening
visit. For the entire duration of the study, participants will maintain a daily diary to
document food and exercise activities to ensure compliance with lifestyle program provided.
At the 4- and 8-weeks visits, the daily diary will be reviewed for food and exercise
activities, and instructions will be provided again to reinforce intervention.
Patients will be provided with glucose meter and glucose strips to measure fingerpick blood
glucose. For the entire duration of the study, patients will be asked to measure their blood
sugars at least one time after exercise and to record any hypoglycemic events (glucose
<70mg/dl) in their diary, Patients will be instructed to record any other untoward side
effects like nausea, vomiting, changes in appetite and other experiences in the diary.
Patients will be instructed to call the Diabetes Center to speak to a study investigator
directly in case of any problem or untoward side effects.
they have a question or side effects.
Standard of care weight loss program:
All patients will be instructed to implement dietary and exercise program for the next 16
weeks and to record their activities on daily food and exercise diary provided.
1. Energy intake should be reduced by 500-750kcal/day.
2. Dietary fat should be reduced to 30% of total energy intake maximally.
3. Meal replacements (if used) will be consumed during breakfast and lunch.
4. Dinner consisted of conventional food and participants will be encouraged to eat fruits
and vegetables within their calorie limit.
5. Participants should ingest 1.0-1.5g of protein/kg/day and spread consumption equally
throughout the day. A leucine-enriched balanced amino acid supplement can be used.
6. Subjects will be instructed to perform aerobic, muscle-strengthening, flexibility, and
balance exercises. Minimally, this should include moderate-intensity aerobic activity
for 30 minutes five days per week or vigorous-intensity aerobic activity for 20 minutes
three days a week, 10-15 repetitions of 8-10 major muscle group strengthening exercises
two or more nonconsecutive days each week, 10 minutes of flexibility activities at least
two days a week, and balance exercises three times a week for fall prevention.
