Clinical trial NCT05885074: Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors
Official title: Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Obesity
Weight Loss
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Obesity increases the risk of cardiometabolic diseases such as hypertension and diabetes. Weight loss interventions such as low-calorie diet and physical activity are effective for weight loss in the short term, but weight loss maintenance (WLM) with low-calorie diet and physical activity is challenging. Weight loss is associated with a reduction in the amount of calories needed to maintain the body at rest, called the resting energy expenditure (REE), which may be a probable mechanism for this lack of WLM. Most individuals are unable to adequately change their diet and increase their physical activity levels to overcome this decrease in REE which prevents WLM. Therefore, techniques that increase REE may promote WLM in these individuals. Pre-clinical studies for Empagliflozin - Sodium-glucose Cotransporter-2 (SGLT2) inhibitor have shown an increase in REE. Thus, in addition to reducing the cardiovascular risk, SGLT2 inhibitor may promote WLM by increasing REE. This study aims to promote WLM in obese individuals by increasing the REE using SGLT2 inhibitor therapy.


Eligibility criteria: Inclusion Criteria:

* Age more than or equal to 18 years
* Body mass index more than or equal to 30 kg/m2 who have lost ≥5% of body weight within the past 6 months without taking any pharmacotherapy for weight loss

Exclusion Criteria:

* Age less than 18 years at screening.
* Untreated systolic BP \<100 or \>160 mmHg at baseline, or diastolic BP \<80 or \>100 mmHg at baseline
* Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)
* Taking pharmacotherapy indicated for weight loss, such as GLP-1 agonists or with weight loss as an adverse event
* History of Type I Diabetes
* History of lung disease
* Have any past or present illness of cardiovascular disease, including myocardial infarction, angina, cardiac arrhythmia, diabetes, stroke, TIA, or seizure
* Current or past (\<12 months) history of smoking
* Estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73 m2 (CKD-EPI equation) urine albumin creatinine ratio ≥30 mg/g
* Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal
* Significant psychiatric illness
* Anemia (men, Hct \< 38%; women, Hct \<36%)
* Inability to exercise on a treadmill
* Consumption of more than 2 alcoholic drinks daily
* Any contraindications to empagliflozin

Primary outcomes:
measure: Change in Resting Energy Expenditure
timeFrame: 12 months
Secondary outcomes:
measure: Change in Body Weight
timeFrame: 12 months
measure: Change in Body Mass Index
timeFrame: 12 months
measure: Change in Waist Circumference
timeFrame: 12 months
measure: Change in HbA1C levels
timeFrame: 12 months
measure: Change in lipid profile
timeFrame: 12 months
measure: Change in HOMA-IR
timeFrame: 12 months
measure: Change in ESR
timeFrame: 12 months
measure: Change in CRP
timeFrame: 12 months
measure: Change in IL-6
timeFrame: 12 months
measure: Change in TNF-α
timeFrame: 12 months
measure: Change in glucagon-like peptide-1 (GLP-1)
timeFrame: 12 months
measure: Change in peptide YY (PYY)
timeFrame: 12 months
measure: Change in ghrelin
timeFrame: 12 months
measure: Change in glucose-dependent insulinotropic polypeptide (GIP)
timeFrame: 12 months
measure: Change in glucagon
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Pankaj Arora, MD, FAHA
role: PRINCIPAL_INVESTIGATOR
References: