NCT03070106Completed
Diabetes: Functional Medicine Approach Vs. Usual Care
Assessment of Diabetes Control, Cost of Care, and Quality of Life Utilizing a Functional Medicine Approach in Addition to Usual Care Vs. Usual Care Alone
Source: ClinicalTrials.gov · Last updated 21 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 87 (actual)
- First submitted
- 20 Feb 2017
- Start date
- 5 Mar 2017
- Primary completion date
- 1 Sept 2023
- Lead sponsor
- Keren Zhou
- Diseases
- Type 2 diabetes
- NCT number
- NCT03070106
What you commit to
- Study type: Interventional
- Participants enrolled: 87
- From 5 Mar 2017 to the primary completion date, 1 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Positive glutamate decarboxylase antibody
- Human Immunodeficiency Virus infection on treatment with medications
- Treatment with steroids (medication related diabetes)
- Treatment with antipsychotics (medication related diabetes)
- Treatment with Coumadin (warfarin)
Other illness
- Use of Insulin Pump for diabetes treatment
- History of Diabetic Ketoacidosis (DKA) defined by patient report or any emergency department visits or hospitalization for DKA
- Known diagnosis of Cognitive Impairment or Dementia
- Congestive Heart Failure New York Heart Association (NYHA) Functional Class III or IV
- Active Malignancy
- Liver Function tests \> 3 times upper limit of normal, Viral Hepatitis, or Elevated Liver Function tests of Unclear Etiology
Lab values
- HbA1c \> 12%
- Abnormal baseline Complete Blood Count
Other
- C peptide \< 0.8 ng/ml
- Pregnancy
- Breastfeeding
- Estimated Glomerular Filtration Rate \< 45 ml/min/1.73m
- Currently participating in a supervised diet program through Department of Endocrinology
- Currently participating in any other research study, such as 15-1134: Prospective Validation of Predictive Tool study through Department of Endocrinology
Who the study is looking for
- 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
Age in the registry: 21 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.