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EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial (EMPOWER-T2D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04531176
Recruitment Status : Active, not recruiting
First Posted : August 28, 2020
Last Update Posted : November 4, 2022
Sponsor:
Information provided by (Responsible Party):
Bartolome Burguera, The Cleveland Clinic

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).


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity 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 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : August 15, 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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
Other: Weight Management Program (WMP)
Weight Management Program (WMP)

Drug: Phentermine / Topiramate Extended Release Oral Capsule
Medication for chronic weight management (Rx)

Drug: naltrexone/bupropion extended-release
Medication for chronic weight management (Rx)

Drug: liraglutide 3.0 mg
Medication for chronic weight management (Rx)

Drug: Orlistat
Medication for chronic weight management (Rx)

Experimental: Obesity-centric approach without AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
Other: Weight Management Program (WMP)
Weight Management Program (WMP)

Active Comparator: Usual care approach (Comorbidity-centric approach)
Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.
Other: Traditional care
Traditional care




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: 12 Months ]
    Measured in percentage

  2. Change in A1C [ Time Frame: 12 Months ]
    Measured in percentage


Secondary Outcome Measures :
  1. Change in body weight [ Time Frame: 24 Months ]
    Measured in percentage

  2. Change in A1C [ Time Frame: 24 Months ]
    Measured in percentage

  3. Efficacy of medication [ Time Frame: 24 Months ]
    Measured in percentage of weight loss

  4. Participants achieving 5% ore more reduction in body weight [ Time Frame: 24 Months ]
    Percentage of participants achieving weight loss at 6, 12 and 24 months

  5. Mean weight loss at 6 months [ Time Frame: 24 Months ]
    Change from baseline in body weight at 6 months

  6. Participants achieving A1c less than 7.0% [ Time Frame: 24 Months ]
    Percentage of participants achieving target of A1C less than 7.0% at 6, 12 and 24 months

  7. Mean A1C at 6 months [ Time Frame: 24 Months ]
    Change from baseline in A1C at 6 months

  8. Mean Serum LDL, HDL [ Time Frame: 24 Months ]
    Change from baseline in serum LDL, HDL at 6, 12 and 24 months

  9. Mean Serum triglycerides [ Time Frame: 24 Months ]
    Change from baseline in serum triglycerides at 6, 12 and 24 months

  10. Participants achieving blood pressure less than 140/90 mmHg [ Time Frame: 24 Months ]
    Percentage of participants achieving target less than 140/90 mmHg at 6, 12 and 24 months

  11. Mean Quality of Life (QOL) questionnaire [ Time Frame: 24 Months ]
    Mean change from baseline in survey scores at 6, 12, 24 months

  12. Mean total cost of care [ Time Frame: 24 Months ]
    Determined per claims data from our EHP at 12 and 24 months



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Type 1 diabetes or known latent autoimmune diabetes of adulthood (LADA)
  2. Glomerular Filtration Rate <30 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration Equation, CKD-EPI)
  3. Current glucocorticoid therapy
  4. Currently or within the past 3 months receiving an anti-obesity medication, or any other medication used for the primary intent of weight loss
  5. 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
  6. Mental incapacity or language barrier
  7. Pregnancy or plans to become pregnant within the next 2 years
  8. Personal or family history of medullary thyroid carcinoma
  9. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2
  10. History of acute pancreatitis, severe liver disease (Cirrhosis), or severe disease of digestive tract
  11. History of congestive heart failure
  12. History of bariatric or metabolic surgery/procedure
  13. Visit with an endocrinologist within the past 1 year
  14. Prior participation in the Endocrinology and Metabolism Institutes Integrated Weight Management Program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531176


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Bartolome Burguera Institute Chairman
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Responsible Party: Bartolome Burguera, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04531176    
Other Study ID Numbers: 20-648
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Liraglutide
Topiramate
Orlistat
Phentermine
Naltrexone
Bupropion
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypoglycemic Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors