Diabetes: Functional Medicine Approach Vs. Usual Care

NCT03070106 | Completed DMC

• 1 other identifier: 16-1339
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

A Functional Medicine (FM) approach to diabetes care focuses on identifying and treating the etiologies for "imbalances in the core physiological systems."(1) If underlying triggers and imbalances can be identified, the FM approach to addressing "root causes"(1) can be utilized through the use of specialized testing to treat and potentially reverse diabetes. If the FM approach is successful, the impact on diabetes disease burden as well as diabetes-associated health care costs could be significant. This project will assess the clinical as well as cost effectiveness of a FM approach to diabetes care compared to a usual care approach for patients with diabetes on insulin for 5 years or less.

Conditions

Diabetes; Type 2 Diabetes; Type 2 Diabetes Treated with Insulin

Outcome Measures

Primary Outcomes (4)

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

  Discontinuation of insulin-no increase in Hemoglobin A1c-6 months

  Baseline to 6 months

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

  Discontinuation of insulin-no increase in Hemoglobin A1c-12 months

  Baseline to 12 months

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

  Discontinuation of insulin-Hemoglobin A1c \<7%-6 months

  Baseline to 6 months

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

  Discontinuation of insulin-Hemoglobin A1c \<7%-12 months

  Baseline to 12 months

Secondary Outcomes (28)

• Number of subjects in each study arm reducing insulin use (units) with no increase in Hemoglobin A1c

  Baseline to 6 months

• Number of subjects in each study arm reducing insulin use (units) with no increase in Hemoglobin A1c

  Baseline to 12 months

• Number of subjects in each study arm reducing insulin use (units) with Hemoglobin A1c <7%

  Baseline to 6 months

• Number of subjects in each study arm reducing insulin use (units) with Hemoglobin A1c <7%

  Baseline to 12 months

• Reduction in the number of units of insulin used by subjects in each study arm with no increase in Hemoglobin A1c

  Baseline to 6 months

Study Arms (2)

Usual Care

NO INTERVENTION

usual care delivered by an endocrinologist

Functional Medicine + Usual Care

ACTIVE COMPARATOR

Functional Medicine in addition to usual care delivered by an endocrinologist

Dietary Supplement: Functional Medicine

Interventions

Functional Medicine DIETARY_SUPPLEMENT

Subjects randomized to the Functional Medicine plus the usual care arm will receive nutrition therapy and dietary supplements. Functional Medicine labs will be used in part to determine which supplements will be prescribed.

Functional Medicine + Usual Care

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Seen in the Cleveland Clinic Main Campus Endocrinology Clinics
• Diagnosis of Type 2 Diabetes
• Insulin treatment for at least 12 months, but for less than 96 months
• Total Daily Insulin Dose \<= 150 units

You may not qualify if:

• Positive glutamate decarboxylase antibody
• C peptide \< 0.8 ng/ml
• Use of Insulin Pump for diabetes treatment
• HbA1c \> 12%
• History of Diabetic Ketoacidosis (DKA) defined by patient report or any emergency department visits or hospitalization for DKA
• Pregnancy
• Breastfeeding
• Known diagnosis of Cognitive Impairment or Dementia
• Estimated Glomerular Filtration Rate \< 45 ml/min/1.73m
• Congestive Heart Failure New York Heart Association (NYHA) Functional Class III or IV
• Active Malignancy
• Human Immunodeficiency Virus infection on treatment with medications
• Treatment with steroids (medication related diabetes)
• Treatment with antipsychotics (medication related diabetes)
• Abnormal baseline Complete Blood Count

Sponsors & Collaborators

• Keren Zhou: lead

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Betul Hatipoglu, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Staff, Endocrinology and Metabolism Institute

Model Details: Comparison between the functional medicine (FM) group and the usual care group

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 3, 2017
• Study Start: March 5, 2017
• Primary Completion: September 1, 2023
• Study Completion: February 1, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)