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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to managing Type 2 Diabetes through Functional Medicine, which aims to identify and address the disease's root causes. It compares the effectiveness of this approach combined with usual care against usual care alone, focusing on health outcomes and costs. The trial seeks participants diagnosed with Type 2 Diabetes who have been on insulin for at least a year but less than eight years, with daily insulin doses of 150 units or less. As an unphased trial, this study offers participants the chance to contribute to innovative research that could transform diabetes care.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but it does exclude people on certain treatments like steroids, antipsychotics, and Coumadin (warfarin). It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a Functional Medicine approach for diabetes appears promising in terms of safety. In a small initial study, patients using this method experienced significant health improvements without major safety issues, indicating that the treatment is generally well-tolerated.

Functional Medicine often includes personalized care plans, which might involve dietary changes, such as a ketogenic diet. Although specific safety data on using this diet for diabetes is limited, ketogenic diets are generally considered safe for many people when closely monitored.

As this treatment is still under research and not widely used, participants should discuss potential risks and benefits with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Functional Medicine approach for Type 2 Diabetes because it provides a personalized treatment plan focusing on nutrition, lifestyle, and holistic health, alongside usual medical care. Unlike standard treatments that primarily rely on medication to control blood sugar levels, this method aims to address the root causes of diabetes by improving overall health and lifestyle. The potential to tailor treatments specifically to individual needs could lead to more effective and sustainable management of Type 2 Diabetes.

What evidence suggests that the Functional Medicine approach might be an effective treatment for Type 2 Diabetes?

Research has shown that a Functional Medicine approach might help manage Type 2 Diabetes. In one study, patients who followed a Functional Medicine program significantly improved their blood sugar levels. Another study found that 6 patients with Type 2 Diabetes stopped taking their diabetes medications, and 5 others reduced their doses by half. Additionally, a personalized digital care program led to a significant drop in HbA1c, a key measure of blood sugar control, by 1.8%. In this trial, participants will receive either usual care from an endocrinologist or a combination of Functional Medicine and usual care. These findings suggest that focusing on individual health needs could be a promising way to manage diabetes effectively. ^{2 4 5 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3373447/

P02.194. Newly developed functional medicine program in ... A functional medicine program piloted in a small group of patients with diabetes was effective. Patients showed significant improvements in traditional clinical ...

2. ifm.org ifm.org/articles/lifestyle-therapies-for-diabetes

Lifestyle Interventions for Type 2 Diabetes In a 2020 study published in The Lancet, researchers found that intensive lifestyle intervention led to significant weight loss at 12 months and was associated ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35687707/

The Use of Personalized Functional Medicine in ... Results: At the end of PFM treatment, 6 patients were completely off T2D-related medications, and 5 had their doses reduced by 50%.

4. nature.com nature.com/articles/s41598-024-76584-7

One-year outcomes of a digital twin intervention for type 2 ... At one-year, participants exhibited significant reductions in HbA1c [mean change: -1.8% (SD 1.7%), p < 0.001], with 1650 (89.0%) achieving HbA1c ...

5. diabetesjournals.org diabetesjournals.org/diabetes/article/69/10/2075/16099/Precision-Medicine-in-Type-2-Diabetes-Using

Precision Medicine in Type 2 Diabetes: Using Individualized ... A negative change is represented an improvement in HbA1c. Mean (SD) improvement in HbA1c was greatest at 6 months for SU −9.4 (8.6) mmol/mol [ ...

6. ifm.org ifm.org/articles/type-2-diabetes-and-the-ketogenic-diet

Type 2 Diabetes and the Ketogenic Diet This article examines the current state of the research and provides considerations for those who may be thinking about using ketogenic diets with their ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3733115/

Comparative Effectiveness and Safety of Medications for Type ... Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations.