Medical Weight Loss Clinical Trial

Medical Weight Loss Clinical Trial

Why participate in the clinical trial?

A clinical trial is a scientific study of how a new treatment can assist people.

By participating in the medical weight loss trial, you will provide more information to help:

  • Patients who are considering medical weight loss options
  • Clinicians who provide care for patients with diabetes or prediabetes
  • Yourself and others who are in a similar situation

What are the benefits of participating in the trial?

  • Preferred scheduling for new patient evaluations
  • A discounted enrollment fee of $75 (standard enrollment fee for the medical weight loss program is $125)
  • Reimbursement of $100 annually for a total of $200 after completion of the two year study
  • Four free dual-energy X-ray absorptiometry (DXA) scans to evaluate bone density and fat mass
  • One free carotid ultrasound screening to check arteries for plaque build up

Do you qualify?

  • Are you willing to drive to Lafayette, Indiana weekly? Or do you have high-speed / smart-phone internet access?
  • Are you between 21 and 65 years of age?
  • Have you been diagnosed with diabetes or prediabetes?
  • Have you had a Hemoglobin A1c above 5.6% in the last six months?
  • Are you overweight or obese?

If you have any of the following medical conditions, you would not qualify for the study:

  • Pregnant, nursing or intention to become pregnant in next two years
  • Renal disease with a serum creatinine over 2
  • History of a myocardial infarction (heart attack) or cardiac surgery in the last six months
  • Active cancer in the last five years

What will be studied?

The study will examine low carbohydrate nutrition as a treatment for Type 2 diabetes and prediabetes. The goal of the study will be to reverse or improve diabetes in patients without the use of medicines and prevent the progression to diabetes in patients who have prediabetes. The study will also be evaluating weight loss and weight maintenance over two years with low carbohydrate nutrition.

How will the study be conducted?

Participants will be assigned to one of two treatment options:

Treatment option 1 - Patients will be treated in the office as a group. The group will meet weekly for three months, then every other week for three months. This will then decrease to monthly for the next six months and every three months for the last year of the study. The treatment option would be ideal for individuals who feel that frequent accountability and interaction may help them achieve their weight loss goals. You will be able to choose from multiple group sessions to accommodate your schedule. Sessions are available during the early morning, lunch or late afternoon and evening.

Treatment option 2 - Patients will receive the same instruction as the first group but they will receive their education and support online. This treatment option would be ideal for individuals who wish to participate but have time conflicts with the group sessions.

Will there be a cost associated with participating in the study?

If you enroll in the study, you will receive a $50 discount on the usual $125 entry fee for the medical weight loss program (i.e., you pay $75). Your insurance will be billed for each office visit and you will be responsible for any copays or deductibles. If you enroll in treatment option 2 (the virtual option) there will be a $75 per month fee for the first five months of the program. Participants in both groups will receive a $100 reimbursement for each year completed for a total of $200 over the two-year period. 

How to get more information?

To learn more about the study or about participating in the clinical trial, please call 765.838.7226 to speak with an Indiana University Health Arnett Bariatrics and Medical Weight Loss team member.

Please note that additional inclusion and exclusion criteria may apply. You can contact the study coordinator at 765.838.7226 for more information.