Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04531176
Status:
TERMINATED
Last Update Posted:
2023-04-11
First Post:
2020-08-10
Brief Title:
EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
An ObEsity-centric Approach With and Without Anti-obesity Medications ComPared to the Usual-care ApprOach to Management of Patients With Obesity and Type 2 Diabetes in an Employer Setting A Pragmatic Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After an unplanned yet IRB approved interim analysis it was found that there was not a significant difference between the 3 arms of the study The study was closed due to futility All Patients are off study and this study will not resume
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPOWER-T2D
Brief Summary:
This is a pragmatic 24 month single-center randomized open-label parallel-group trial comparing an obesity-centric approach with a medically-supervised and comprehensive weight loss program Cleveland Clinics Endocrinology and Metabolism Institutes Integrated Weight Management Program augmented by AOMs vs an obesity-centric approach with a medically-supervised and comprehensive weight loss program without AOMs vs the current usual care approach to general health management
Informed consent will be obtained IRB approval of the study will be obtained 300 subjects employees or spouses covered by our EHP will be randomized 111 to receive either an obesity-centric approach with AOM therapy N100 an obesity-centric approach without AOM therapy N100 or the current usual care approach to general health management N100
Informed consent will be obtained IRB approval of the study will be obtained 300 subjects employees or spouses covered by our EHP will be randomized 111 to receive either an obesity-centric approach with AOM therapy N100 an obesity-centric approach without AOM therapy N100 or the current usual care approach to general health management N100
Detailed Description:
Obesity affects nearly 40 of adults in the US and it is responsible for important medical problems including hypertension dyslipidemia T2D depression coronary heart disease stroke osteoarthritis obstructive sleep apnea OSA fatty liver disease and some cancers to name a few45
Obesity is responsible for the development of T2D and hypertension in more than 90 and 50 of cases respectively6-7 Also more than 70 of patients with obesity have dyslipidemia The prevalence of depression in patients with obesity is more than 50 and obesity is responsible for causing osteoarthritis in more than 25 of the patients8 Also in the adult population the prevalence of OSA is estimated to be 25 and as high as 45 in subjects with obesity9
Patients with obesity have an increased risk of all-cause and cardiovascular death In recognition of the biologic basis and seriousness of obesity several professional health associations and organizations worldwide recognize obesity as a disease10
Even though there is clear evidence in the literature that weight loss is associated with a dramatic improvement of obesity-related comorbidities and the patients quality of life in general clinicians all over the world focus their attention on treating the diabetes hypertension hyperlipidemia and other comorbidities rather than the obesity itself concentrating their efforts on improving blood glucose indices blood pressure and LDL as well as triglycerides and in many instances prescribing anti-diabetes and antihypertensive medications that potentiate further weight gain1112 As a result clinicians are faced with a rising epidemic of obesity perpetuating a preexisting epidemic of diabetes hypertension dyslipidemia and metabolic syndrome
Obesity is one of the biggest drivers of preventable chronic diseases and healthcare costs in the United States Currently estimates for these costs are 210 billion per year In addition obesity is associated with job absenteeism and with lower productivity while at work costing approximately 43 billion annually1213
As a persons BMI increases so do the number of sick days medical claims and healthcare costs Individuals who suffer obesity spend 42 more on direct healthcare costs than adults who have a healthy weight Individuals with grade 1 obesity BMI between 30 and 35 are more than twice as likely as individuals with BMI 30 to be prescribed prescription pharmaceuticals to manage medical conditions14
Reducing obesity improving nutrition increasing physical activity and making lifelong meaningful lifestyle changes can help lower costs through fewer doctors office visits tests prescription drugs sick days emergency room visits and admissions to the hospital and lower the risk for a wide range of diseases
A 2008 study by the Urban Institute The New York Academy of Medicine and Trust for Americas Health found that an investment of 10 per person in proven community-based programs to increase physical activity improve nutrition and prevent smoking and other tobacco use could save the country more than 16 billion annually within five years Thats a return of 560 for every 1 invested15
In spite of these important facts there is a significant yet much-underutilized role for structured weight management programs both with and without use of anti-obesity medications to improve metabolic control for patients with obesity who have developed comorbidities such as hypertension hyperlipidemia and T2D Unfortunately these patients have a much higher risk of developing coronary artery disease and cancer
The medical literature contains ample evidence which demonstrates the positive impact that a lifestyle intervention program augmented by FDA approved AOMs can have on anthropometric and metabolic parameters in patients with obesity who have developed significant comorbidities16-17 Lifestyle intervention in the form of improving diet eating behaviors and increasing physical activity is first-line treatment for obesity and overweight but the majority of people with obesity and overweight struggle to achieve and maintain their weight loss long-term We hypothesize that an obesity-centric approach delivered through a medically-supervised and comprehensive weight loss program18 augmented by AOM as the primary treatment of patients with obesity and T2D will result in greater and sustainable weight loss a better metabolic profile including glycemic blood pressure and cholesterol control and improved quality of life QOL and treatment satisfaction when compared to an obesity-centric approach without AOM therapy or the current usual carestandard of care comorbidity-centric approach to general health management in patients with obesity and T2D If confirmed these findings would be expected to change our future approach to chronic diseases management and reduce the rates of T2D hypertension and hyperlipidemia related complications including heart disease and cancer as well as the development of other obesity-related comorbidities potentially reducing the long-term cost of care
Obesity is responsible for the development of T2D and hypertension in more than 90 and 50 of cases respectively6-7 Also more than 70 of patients with obesity have dyslipidemia The prevalence of depression in patients with obesity is more than 50 and obesity is responsible for causing osteoarthritis in more than 25 of the patients8 Also in the adult population the prevalence of OSA is estimated to be 25 and as high as 45 in subjects with obesity9
Patients with obesity have an increased risk of all-cause and cardiovascular death In recognition of the biologic basis and seriousness of obesity several professional health associations and organizations worldwide recognize obesity as a disease10
Even though there is clear evidence in the literature that weight loss is associated with a dramatic improvement of obesity-related comorbidities and the patients quality of life in general clinicians all over the world focus their attention on treating the diabetes hypertension hyperlipidemia and other comorbidities rather than the obesity itself concentrating their efforts on improving blood glucose indices blood pressure and LDL as well as triglycerides and in many instances prescribing anti-diabetes and antihypertensive medications that potentiate further weight gain1112 As a result clinicians are faced with a rising epidemic of obesity perpetuating a preexisting epidemic of diabetes hypertension dyslipidemia and metabolic syndrome
Obesity is one of the biggest drivers of preventable chronic diseases and healthcare costs in the United States Currently estimates for these costs are 210 billion per year In addition obesity is associated with job absenteeism and with lower productivity while at work costing approximately 43 billion annually1213
As a persons BMI increases so do the number of sick days medical claims and healthcare costs Individuals who suffer obesity spend 42 more on direct healthcare costs than adults who have a healthy weight Individuals with grade 1 obesity BMI between 30 and 35 are more than twice as likely as individuals with BMI 30 to be prescribed prescription pharmaceuticals to manage medical conditions14
Reducing obesity improving nutrition increasing physical activity and making lifelong meaningful lifestyle changes can help lower costs through fewer doctors office visits tests prescription drugs sick days emergency room visits and admissions to the hospital and lower the risk for a wide range of diseases
A 2008 study by the Urban Institute The New York Academy of Medicine and Trust for Americas Health found that an investment of 10 per person in proven community-based programs to increase physical activity improve nutrition and prevent smoking and other tobacco use could save the country more than 16 billion annually within five years Thats a return of 560 for every 1 invested15
In spite of these important facts there is a significant yet much-underutilized role for structured weight management programs both with and without use of anti-obesity medications to improve metabolic control for patients with obesity who have developed comorbidities such as hypertension hyperlipidemia and T2D Unfortunately these patients have a much higher risk of developing coronary artery disease and cancer
The medical literature contains ample evidence which demonstrates the positive impact that a lifestyle intervention program augmented by FDA approved AOMs can have on anthropometric and metabolic parameters in patients with obesity who have developed significant comorbidities16-17 Lifestyle intervention in the form of improving diet eating behaviors and increasing physical activity is first-line treatment for obesity and overweight but the majority of people with obesity and overweight struggle to achieve and maintain their weight loss long-term We hypothesize that an obesity-centric approach delivered through a medically-supervised and comprehensive weight loss program18 augmented by AOM as the primary treatment of patients with obesity and T2D will result in greater and sustainable weight loss a better metabolic profile including glycemic blood pressure and cholesterol control and improved quality of life QOL and treatment satisfaction when compared to an obesity-centric approach without AOM therapy or the current usual carestandard of care comorbidity-centric approach to general health management in patients with obesity and T2D If confirmed these findings would be expected to change our future approach to chronic diseases management and reduce the rates of T2D hypertension and hyperlipidemia related complications including heart disease and cancer as well as the development of other obesity-related comorbidities potentially reducing the long-term cost of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None