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Diabetes: Functional Medicine Approach Vs. Usual Care

NCT03070106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-03-21

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Functional Medicine

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.

Sponsors & Collaborators

  • Keren Zhou

    lead OTHER

Principal Investigators

  • Betul Hatipoglu, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-05
Primary Completion
2023-09-01
Completion
2025-02-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03070106 on ClinicalTrials.gov