EMI‑EHP Weight Management and Type 2 Diabetes Pragmatic Trial

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Information provided by:

The Cleveland Clinic

Last updated:

11/04/2022

Trial identifier:

NCT04531176

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Simplified Study Description Detailed Study Description

Study Description

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 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).

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 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

Official Title

Glossary term:

Title

The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.

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

Type of Study

Glossary term:

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access. Interventional studies (clinical trials): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational studies: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific intervention/treatment. A patient registry is a type of observational study. Expanded access: A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.

Interventional

Enrollment (Actual)

Glossary term:

Enrollment

The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

Phase

Glossary term:

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies). Phase 1: Clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. Phase 2: Clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. Phase 3: Clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. Phase 4: Clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use. Not Applicable: Trials without FDA-defined phases, including trials of devices or behavioral interventions.

Phase 4

Other Study ID Numbers

Glossary term:

Other study IDs

Identifiers or ID numbers other than the NCT number that are assigned to a clinicalstudy by the study's sponsor, funders, or others. These numbers may include unique identifiers from othertrial registries and National Institutes of Health grant numbers.

20-648

Intervention / Treatment

Glossary term:

Intervention/treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Other: Weight Management Program (WMP)
Other: Traditional care
Drug: Phentermine / Topiramate Extended Release Oral Capsule
Drug: naltrexone/bupropion extended-release
Drug: liraglutide 3.0 mg
Drug: Orlistat

Study Start (Actual)

Glossary term:

Study start date

The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Sep 01, 2020

Primary Completion (Actual)

Glossary term:

Primary completion date

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.

Aug 15, 2022

Study Completion (Anticipated)

Glossary term:

Study completion date

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.

Mar 01, 2023

First Submitted Date

Glossary term:

First submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).

Aug 10, 2020

First Submitted that Met QC Criteria

Glossary term:

First submitted that met QC criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

Aug 27, 2020

First Posted (Actual)

Glossary term:

First posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.

Aug 28, 2020

Last Update Submitted that Met MQ Criteria

Glossary term:

Last update submitted that met QC criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

Nov 03, 2022

Last Update Posted (Actual)

Glossary term:

Last update posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date)and the last update posted date.

Nov 04, 2022

Other important Dates

Contacts and Locations

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Get Directions

Contacts and Locations

Locations (1)

Cleveland Clinic

Cleveland, Ohio 44195

United States

Get Directions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. For general information about clinical research, read Guides to Clinical Trials.

Eligibility Criteria

Ages Eligible for Study:

Glossary term:

Age

A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

18 Years - 75 Years

Accepts Healthy Volunteers:

Glossary term:

Accepts Healthy Volunteers

A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

Sexes Eligible for Study:

Glossary term:

Sex

A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

All

Description:

Inclusion Criteria:

Gender: men and women
Ethnicity: all ethnic groups
Age: ≥18, < 75 years
Diagnosis of T2D -A1C within the last 90 days must be >7.5%
Obesity, BMI ≥30
An Employee, or the significant other of an employee, that is covered by the Cleveland Clinic Employee Health Plan

Exclusion Criteria:

Type 1 diabetes or known latent autoimmune diabetes of adulthood (LADA)
Glomerular Filtration Rate <30 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration Equation, CKD-EPI)
Current glucocorticoid therapy
Currently or within the past 3 months receiving an anti-obesity medication, or any other medication used for the primary intent of weight loss
Any condition, unwillingness or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol
Mental incapacity or language barrier
Pregnancy or plans to become pregnant within the next 2 years
Personal or family history of medullary thyroid carcinoma
Personal or family history of Multiple Endocrine Neoplasia syndrome type 2
History of acute pancreatitis, severe liver disease (Cirrhosis), or severe disease of digestive tract
History of congestive heart failure
History of bariatric or metabolic surgery/procedure
Visit with an endocrinologist within the past 1 year
Prior participation in the Endocrinology and Metabolism Institutes Integrated Weight Management Program

Study Plan

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

How is the study designed?

Design Details:

Primary Purpose:

Treatment

Allocation:

Randomized

Interventional Model:

Parallel Assignment

Number of Arms:

Arms and Interventions:

Participant Group / Arm

Glossary term:

Arm

A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.

Intervention / Treatment

Glossary term:

Intervention/treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Experimental: Obesity-centric approach + AOM

Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg

Experimental: Obesity-centric approach + AOM

Other: Weight Management Program (WMP)

Weight Management Program (WMP)

Other: Weight Management Program (WMP)

Weight Management Program (WMP)

Drug: Phentermine / Topiramate Extended Release Oral Capsule