Back to resultsMechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors
Primary Purpose
Obesity, Weight Loss
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Empagliflozin Arm
Control Arm
Exercise capacity VO2 maximum determination
Exercise Challenge
Sponsored by
About this trial
This is an interventional basic science trial for Obesity
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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Empagliflozin Arm
Placebo Arm
Arm Description
Investigator will enroll 12 obese participants who have intentionally lost greater than or equal to 5% of body weight through a non-pharmacological structured weight loss program based on diet and exercise within the last 6 months. The participants will take empagliflozin 25mg/day orally for 12 months.
Investigator will enroll 12 obese participants who have intentionally lost greater than or equal to 5% of body weight through a non-pharmacological structured weight loss program based on diet and exercise within the last 6 months. The participants will take a placebo pill orally once a day for 12 months.
Outcomes
Primary Outcome Measures
Change in Resting Energy Expenditure
Change in Resting Energy Expenditure between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Secondary Outcome Measures
Change in Body Weight
Change in Body Weight between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in Body Mass Index
Change in Body Mass Index between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in Waist Circumference
Change in Waist Circumference between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in HbA1C levels
Change in HbA1C levels between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in lipid profile
Change in Lipid profile between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in HOMA-IR
Change in HOMA-IR between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in ESR
Change in ESR between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in CRP
Change in CRP between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in IL-6
Change in IL-6 between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in TNF-α
Change in TNF-α between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in glucagon-like peptide-1 (GLP-1)
Change in glucagon-like peptide-1 (GLP-1) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in peptide YY (PYY)
Change in peptide YY (PYY) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in ghrelin
Change in ghrelin between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in glucose-dependent insulinotropic polypeptide (GIP)
Change in glucose-dependent insulinotropic polypeptide (GIP) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in glucagon
Change in glucagon between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Full Information
NCT ID
NCT05885074
First Posted
May 11, 2023
Last Updated
September 29, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05885074
Brief Title
Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors
Official Title
Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 30, 2024 (Anticipated)
Primary Completion Date
January 30, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Empagliflozin Arm
Arm Type
Experimental
Arm Description
Investigator will enroll 12 obese participants who have intentionally lost greater than or equal to 5% of body weight through a non-pharmacological structured weight loss program based on diet and exercise within the last 6 months. The participants will take empagliflozin 25mg/day orally for 12 months.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Investigator will enroll 12 obese participants who have intentionally lost greater than or equal to 5% of body weight through a non-pharmacological structured weight loss program based on diet and exercise within the last 6 months. The participants will take a placebo pill orally once a day for 12 months.
Intervention Type
Drug
Intervention Name(s)
Empagliflozin Arm
Intervention Description
The subject will be randomized, in a double-blind manner to Empagliflozin 25mg once daily for a period of 12 months
Intervention Type
Other
Intervention Name(s)
Control Arm
Intervention Description
The subject will be randomized, in a double-blind manner to receive placebo once daily for a period of 12 months
Intervention Type
Other
Intervention Name(s)
Exercise capacity VO2 maximum determination
Intervention Description
Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol and will also undergo a DEXA scan to determine the body mass.
Intervention Type
Other
Intervention Name(s)
Exercise Challenge
Intervention Description
Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill and will also undergo a resting energy expenditure test.
Primary Outcome Measure Information:
Title
Change in Resting Energy Expenditure
Description
Change in Resting Energy Expenditure between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Body Weight
Description
Change in Body Weight between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in Body Mass Index
Description
Change in Body Mass Index between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in Waist Circumference
Description
Change in Waist Circumference between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in HbA1C levels
Description
Change in HbA1C levels between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in lipid profile
Description
Change in Lipid profile between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in HOMA-IR
Description
Change in HOMA-IR between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in ESR
Description
Change in ESR between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in CRP
Description
Change in CRP between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in IL-6
Description
Change in IL-6 between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in TNF-α
Description
Change in TNF-α between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in glucagon-like peptide-1 (GLP-1)
Description
Change in glucagon-like peptide-1 (GLP-1) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in peptide YY (PYY)
Description
Change in peptide YY (PYY) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in ghrelin
Description
Change in ghrelin between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in glucose-dependent insulinotropic polypeptide (GIP)
Description
Change in glucose-dependent insulinotropic polypeptide (GIP) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
Title
Change in glucagon
Description
Change in glucagon between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nehal Vekariya, MS
Phone
2059347173
Email
nvekariya@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Weber, BSN, RN
Phone
205-975-9964
Email
dlowe@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pankaj Arora, MD, FAHA
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nehal Vekariya
Phone
205-934-7173
Email
nvekariya@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Pankaj Arora, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors
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