What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include metformin, sulfonylureas, GLP-1 receptor agonists, and SGLT2 inhibitors. Metformin is generally well-tolerated but can cause gastrointestinal issues such as diarrhea and nausea. Sulfonylureas may lead to hypoglycemia and weight gain. GLP-1 receptor agonists can cause gastrointestinal symptoms like nausea and vomiting, and have been associated with a reduced risk of cardiovascular events. SGLT2 inhibitors may lead to urinary tract infections, genital infections, and have a noted risk of lower limb amputations in some studies. These treatments aim to manage blood glucose levels and address underlying physiological imbalances, aligning with the Functional Medicine approach.

What other types of research exist?

Promising novel alternatives to the Functional Medicine Approach for Type 2 Diabetes patients in 2024 include: 1) Incretin mimetics (GLP-1 receptor agonists and SGLT2 inhibitors) which have shown efficacy in lowering glucose levels and reducing cardiovascular events. 2) Combination glucose-lowering therapies that do not rely on metformin, offering various drug combinations tailored to individual patient needs. 3) Metabolic surgery, such as Roux-en-Y gastric bypass or sleeve gastrectomy, which has demonstrated significant improvements in glycemic control and remission rates in T2DM patients.

← Back to Search

Other

Functional Medicine Approach for Type 2 Diabetes

Q: What is the mechanism of action of this treatment?

Common treatments for Type 2 Diabetes include metformin, which decreases hepatic glucose production and increases insulin sensitivity; sulfonylureas, which stimulate insulin secretion from pancreatic β-cells; and incretin-based therapies like GLP-1 receptor agonists and DPP-4 inhibitors, which enhance insulin secretion and inhibit glucagon release. Understanding these mechanisms is crucial for T2DM patients as it helps tailor treatments to individual needs, potentially improving glycemic control and reducing complications. The Functional Medicine approach aligns with this by addressing root causes and imbalances in physiological systems, aiming for more personalized and effective management of diabetes.

Q: What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes that align with the Functional Medicine approach by targeting specific physiological pathways. These include GLP-1 receptor agonists like liraglutide and exenatide, which enhance insulin secretion and inhibit glucagon release, and SGLT2 inhibitors like canagliflozin, which reduce glucose reabsorption in the kidneys. These drugs not only help in glycemic control but also address underlying metabolic imbalances, making them relevant to the FM approach.

N/A

Waitlist Available

Led By Betul Hatipoglu, MD

Research Sponsored by Keren Zhou

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Type 2 Diabetes

Total Daily Insulin Dose <= 150 units

Must not have

History of Diabetic Ketoacidosis (DKA) defined by patient report or any emergency department visits or hospitalization for DKA

Estimated Glomerular Filtration Rate < 45 ml/min/1.73m

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

No Placebo-Only Group

Summary

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 the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves a non-pharmaceutical approach focusing on lifestyle changes and possibly supplements based on individual assessments rather than drugs, specific side effects are not listed as they would vary greatly depending on the personalized treatments prescribed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Type 2 Diabetes.

Select...

I use 150 units of insulin or less daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

My kidney function is reduced.

Select...

I have tested positive for the glutamate decarboxylase antibody.

Select...

I am HIV positive and currently on medication.

Select...

I currently have cancer.

Select...

I am taking antipsychotics that may affect my blood sugar levels.

Select...

My liver tests are more than three times the normal limit, or I have viral hepatitis, or my liver tests are high for an unknown reason.

Select...

I am currently taking Coumadin (warfarin).

Select...

My heart condition severely limits my physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of subjects in each study arm discontinuing insulin use with Hemoglobin A1c <7%

Number of subjects in each study arm discontinuing insulin use with no increase in Hemoglobin A1c

Secondary study objectives

Change in body weight (kg) for subjects in each study arm

Change in high density lipoprotein [HDL] (mg/dL) for subjects in each study arm

Change in low density lipoprotein [LDL] (mg/dL) for subjects in each study arm

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Usual CareActive Control1 Intervention

usual care delivered by an endocrinologist

Group II: Functional Medicine + Usual CareActive Control1 Intervention

Functional Medicine in addition to usual care delivered by an endocrinologist

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include metformin, which decreases hepatic glucose production and increases insulin sensitivity; sulfonylureas, which stimulate insulin secretion from pancreatic β-cells; and incretin-based therapies like GLP-1 receptor agonists and DPP-4 inhibitors, which enhance insulin secretion and inhibit glucagon release. Understanding these mechanisms is crucial for T2DM patients as it helps tailor treatments to individual needs, potentially improving glycemic control and reducing complications. The Functional Medicine approach aligns with this by addressing root causes and imbalances in physiological systems, aiming for more personalized and effective management of diabetes.

Assessing the quality of the evidence underlying recommendations in type 2 diabetes' commonly used clinical practice guidelines.The Mystery of Diabetic Cardiomyopathy: From Early Concepts and Underlying Mechanisms to Novel Therapeutic Possibilities.Pharmacological Intervention in Type 2 Diabetes Mellitus - A Pathophysiologically Reasoned Approach?