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Vibegron for ENergy Thinking and Resilience in Aging

ConditionObesity
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age45-75
SponsorWake Forest University Health Sciences

About this trial

This 12-week randomized, double-blind, placebo-controlled trial will test the hypothesis that Vibegron (brand name GEMTESA) can improve energy metabolism, cardiometabolic risk factors, and physical and cognitive function in middle-aged and older adults with obesity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Obese (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with a waist circumference >102 cm for men and >88 cm for women)

Disqualifiers

Body weight ≥450 pounds

Major depression

Evidence of cognitive impairment

Uncontrolled diabetes (hemoglobin A1c >7%)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vibegron

    Drug

    A drug in a class of medications called beta-3 adrenergic agonists; approved for use with Overactive Bladder; 75mg tablets will be used in this study

  • Placebo

    Drug

    Tablets made of inert substance that looks like the vibegron tablets but has no therapeutic value

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: VibegronExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Resting Metabolic Rate

Resting metabolic rate (RMR) will be measured by indirect calorimetry using a computerized metabolic cart that provides valid and reliable measurement of oxygen consumption and carbon dioxide production - RMR can be estimated using formulas such as the Mifflin-St Jeor equation: Males: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) + 5 Females: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) - 161

Time frame
Baseline
2

Resting Metabolic Rate

Resting metabolic rate (RMR) will be measured by indirect calorimetry using a computerized metabolic cart that provides valid and reliable measurement of oxygen consumption and carbon dioxide production - RMR can be estimated using formulas such as the Mifflin-St Jeor equation: Males: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) + 5 Females: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) - 161

Time frame
Week 12

Secondary outcomes

1

Glucose Tolerance Level

Glucose tolerance will be assessed using a standard 75-g oral glucose load to measure changes in glucose and insulin levels. Glucose tolerance will be defined as the 2-hour glucose level - a normal two-hour post-glucose level is below 140 mg/dL (7.8 mmol/L). Levels between 140 and 199 mg/dL (7.8 and 11 mmol/L) indicate impaired glucose tolerance (also called prediabetes), while levels of 200 mg/dL (11.1 mmol/L) or higher suggest diabetes.

Time frame
Baseline and Week 12
2

Expanded Short Physical Performance Battery (eSPPB)

Lower extremity function will be assessed using the eSPPB which measures balance, gait speed, and leg strength - Each component is scored separately, and then the scores are summed to give a total score ranging from 0 (worst) to 12 (best) - The total score is calculated by summing the scores from the three subtests. A higher total score indicates better lower extremity function, while a lower score indicates more functional limitations.

Time frame
Baseline and Week 12

Other outcomes

1

Core body temperature

Core body temperature will be measured continuously using a temperature monitoring patch worn on the chest.

Time frame
Baseline and Week 12
2

Lipid levels

Plasma levels of total cholesterol, VLDL cholesterol, HDL cholesterol, and triglycerides will be measured in fasted blood samples.

Time frame
Baseline, Week 4, and Week 12
3

Depressive Symptoms: 15-item Geriatric Depression Scale (GDS-15)

Questionnaire used to measure depressive symptoms in the elderly; ranges from 0-15 with higher scores indicating greater severity of depression; score of 0-4 is within normal range; score of 5-8 mild depression; score of 9-11 moderate depression; score of 12-15 severe depression

Time frame
Baseline and Week 12
4

Quality of Life: Medical Outcomes Study Short Form 36 (SF-36)

Quality of life questionnaire with a score that ranges from 0 to 100 with higher scores indicating better quality of life.

Time frame
Baseline and Week 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: