Functional Medicine Approach for Type 2 Diabetes

Overseen By Sarah Schramm

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Keren Zhou

Must be taking: Insulin

Must not be taking: Steroids, Antipsychotics, Coumadin

Disqualifiers: Pregnancy, Dementia, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 24 months

87 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a special type of medical care that looks for and treats the root causes of diabetes, combined with regular diabetes care. It targets patients with diabetes who have been on insulin for a short period. The goal is to see if this approach can improve or even reverse their condition by using specialized tests and personalized treatments.

Who Is on the Research Team?

Betul Hatipoglu, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for people who have been treated with insulin for Type 2 Diabetes at the Cleveland Clinic Main Campus Endocrinology Clinics, between 12 and 96 months, using no more than 150 units of insulin daily. It's not for those with severe heart failure, cognitive issues, on certain diets or other studies, using an insulin pump, extremely high HbA1c levels (>12%), pregnant or breastfeeding women, or those with various health conditions like active cancer.

Inclusion Criteria

Seen in the Cleveland Clinic Main Campus Endocrinology Clinics

I have been diagnosed with Type 2 Diabetes.

I have been on insulin for 1 to 8 years.

Exclusion Criteria

Pregnancy

Your C peptide level is less than 0.8 ng/ml.

I have been hospitalized or visited the ER for diabetic ketoacidosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants complete a baseline visit including lab data/biometrics and quality of life instruments

1 week

1 visit (in-person)

Treatment

Participants receive either usual care or Functional Medicine plus usual care, with evaluations at 6, 12, and 24 months

24 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Functional Medicine

Trial Overview The study compares a Functional Medicine approach that targets root causes of diabetes through specialized testing and treatment against usual care methods. The goal is to see if this can treat or even reverse diabetes over time while also being cost-effective.

How Is the Trial Designed?

Group I: Usual Care Active Control 1 Intervention

usual care delivered by an endocrinologist

Group II: Functional Medicine + Usual Care Active Control 1 Intervention

Functional Medicine in addition to usual care delivered by an endocrinologist

Who Is Running the Clinical Trial?

Keren Zhou

Lead Sponsor

Trials

1

Recruited

90+