Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04531176 |
| Other study ID # |
20-648 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
June 2023 |
Study information
| Verified date |
April 2023 |
| Source |
The Cleveland Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 Clinic's Endocrinology and Metabolism Institute's 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 1:1:1 to receive either an
obesity-centric approach with AOM therapy (N=100), an obesity-centric approach without AOM
therapy (N=100), or the current usual care approach to general health management (N=100).
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 few4,5.
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 patient's 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 gain11,12. 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 $4.3 billion annually12,13.
As a person's 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 doctor's 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 America's
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. That's a return of
$5.60 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 care/standard 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
