Trial · Interventional

TerminatedPhase 4Results postedRegistry data

EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial

Short name EMPOWER-T2D

NCTNCT04531176Other id20-648

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: 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.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 74 participants (actual)
Sponsor: The Cleveland Clinic · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 1 Sept 2020
Primary completion: 15 Aug 2022
Completion: 4 Aug 2023
First posted: 28 Aug 2020
Last update posted: 19 Sept 2024
Conditions: Type 2 Diabetes · Obesity

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20202021202220232024

Ph 4
EMPOWER-T2D
NCT04531176
1 Sept 2020 to 4 Aug 2023
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

Weight Management Program (WMP)Other
Traditional careOther
Phentermine / Topiramate Extended Release Oral CapsuleDrug
naltrexone/bupropion extended-releaseDrug
liraglutide 3.0 mgDrug
OrlistatDrug

Arms3

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 without AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
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.

Primary outcomes2

Outcomes the sponsor listed as primary.

Mean Change in Body Weight Between Baseline and 12 Months
Time frame · 12 Months
Registry description
All relevant time points used in the calculation in the Time Frame between baseline and 12 months. Measured in the mean Change in body weight between baseline and 12 months measured in percentage (%) of body weight loss
Mean Change in A1C
Time frame · 12 Months
Registry description
All relevant time points used in the calculation in the Time Frame between baseline and 12 months. Measured in the mean change of the percentage of glycosylated hemoglobin from baseline to 12 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 Months

Mean Change in Body Weight Between Baseline and 12 Months

Group	Value (% of body weight)
Obesity-centric Approach + AOM	-8.74
Obesity-centric Approach Without AOM	-6.68
Usual Care Approach (Comorbidity-centric Approach)	-4.48

Primary outcomeMean· 12 Months

Mean Change in A1C

Group	Value (Percentage of glycosylated hemoglobin)
Obesity-centric Approach + AOM	-2.18
Obesity-centric Approach Without AOM	-2.22
Usual Care Approach (Comorbidity-centric Approach)	-1.65

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Obesity-centric Approach + AOMParticipants 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 Weight Management Program (WMP): Weight Management Program (WMP) Phentermine / Topiramate Extended Release Oral Capsule: Medication for chronic weight management (Rx) naltrexone/bupropion extended-release: Medication for chronic weight management (Rx) liraglutide 3.0 mg: Medication for chronic weight management (Rx) Orlistat: Medication for chronic weight management (Rx)	0 / 24	0 / 24	3 / 24
Obesity-centric Approach Without AOMParticipants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years. Weight Management Program (WMP): Weight Management Program (WMP)	0 / 23	1 / 23	0 / 23
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. Traditional care: Traditional care	0 / 23	0 / 23	2 / 23

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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