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.
This is a prospective, randomized, controlled, open-label clinical trial with a 1:1 randomization of patients with diabetes who have been on insulin less than 5 years to receive either Functional Medicine care in addition to usual care or to continue usual care delivered by an endocrinologist. The total number of patients planned for enrollment is 90, 45 in each arm. Patient recruitment will begin in the Cleveland Clinic main campus Endocrinology clinics and may later include Endocrinology practices at other Cleveland Clinic Health System sites. Following voluntary informed consent, study subjects will complete a screening/baseline visit. After this visit, patients will be randomized to continuing usual care delivered by endocrinologists or to FM plus usual care. Once randomization occurs, the patient will continue to remain under the care of their endocrinologist and any other usual physicians. If randomized to the FM plus usual care group, subjects will receive additional care through a functional medicine physician. A stratified randomization procedure will be used to allocate patients into the two groups according to the strata: Total Daily Insulin dose \< = 50 units vs. \> 50 units. All subjects: In addition to usual care provided by the endocrinologist, study visits will occur at screening/baseline, 6 months, 12 months and 24 months. Lab data/Biometrics (if not recorded within 1 month time frame) will be obtained at this time. Quality of life instruments (Diabetes Distress Scale, SPADE, PHQ-9 and MSQ; Appendices D, E, F and G) will also be administered. At baseline, the 12 month visit, and the 24 month visit, a Body Fat Analysis by Bioelectrical impedance analysis (BIA) will be performed. There will also be 10 cc of blood collected for plasma and serum samples as well as 10 cc of urine and approximately 1 gram of stool for the bio repository if patient agrees to provide the samples. Usual care subjects only: Subjects randomized to the usual care arm will receive a nutritional education session. FM plus usual care subjects only: Subjects randomized to the FM plus usual care arm will be evaluated using the functional medicine approach to diabetes outlined in the Functional Medicine Diagnostic and Treatment Approach to Type 2 Diabetes Mellitus and Cardio-Metabolic Syndrome. Subjects randomized to the FM plus usual care arm will also receive nutrition therapy and dietary supplements. These will be prescribed and monitored at all Functional Medicine study visits. An estimated total of 50ml of blood will be collected from those subjects in this arm of the study at each designated visit. In addition, subjects may be asked to provide a urine and stool sample. Functional Medicine labs will be used in part to determine which supplements will be recommended.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
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.
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 12 months
Number of subjects in each study arm reducing insulin use (units) with no increase in Hemoglobin A1c
Reduction in insulin use-no increase in Hemoglobin A1c-6 months
Time frame: Baseline to 6 months
Number of subjects in each study arm reducing insulin use (units) with no increase in Hemoglobin A1c
Reduction in insulin use-no increase in Hemoglobin A1c-12 months
Time frame: Baseline to 12 months
Number of subjects in each study arm reducing insulin use (units) with Hemoglobin A1c <7%
Reduction in insulin use-Hemoglobin A1c \<7%-6 months
Time frame: Baseline to 6 months
Number of subjects in each study arm reducing insulin use (units) with Hemoglobin A1c <7%
Reduction in insulin use-Hemoglobin A1c \<7%-12 months
Time frame: 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
Reduction in number of insulin units-no increase in Hemoglobin A1c-6 months
Time frame: Baseline to 6 months
Reduction in the number of units of insulin used by subjects in each study arm with no increase in Hemoglobin A1c
Reduction in number of insulin units-no increase in Hemoglobin A1c-12 months
Time frame: Baseline to 12 months
Reduction in the number of units of insulin used by subjects in each study arm with Hemoglobin A1c <7%
Reduction in number of insulin units-Hemoglobin A1c \<7%-6 months
Time frame: Baseline to 6 months
Reduction in the number of units of insulin used by subjects in each study arm with Hemoglobin A1c <7%
Reduction in number of insulin units-Hemoglobin A1c \<7%-12 months
Time frame: Baseline to 12 months
Total reduction in Hemoglobin A1c percentage for subjects in each study arm
Evaluate diabetes control using subject hemoglobin A1c values-6 months
Time frame: Baseline to 6 months
Total reduction in Hemoglobin A1c percentage for subjects in each study arm
Evaluate diabetes control using subject hemoglobin A1c values-12 months
Time frame: Baseline to 12 months
Change in low density lipoprotein [LDL] (mg/dL) for subjects in each study arm
Evaluate cardiovascular risk factor using Low density lipoprotein values-6 months
Time frame: Baseline to 6 months
Change in low density lipoprotein [LDL] (mg/dL) for subjects in each study arm
Evaluate cardiovascular risk factor using Low density lipoprotein values-12 months
Time frame: Baseline to 12 months
Change in high density lipoprotein [HDL] (mg/dL) for subjects in each study arm
Evaluate cardiovascular risk factor using High density lipoprotein (HDL)-6 months
Time frame: Baseline to 6 months
Change in high density lipoprotein [HDL] (mg/dL) for subjects in each study arm
Evaluate cardiovascular risk factor using High density lipoprotein (HDL)-12 months
Time frame: Baseline to 12 months
Change in systolic blood pressure (mm/Hg) for subjects in each study arm
Evaluate cardiovascular risk factor using systolic blood pressure-6 months
Time frame: Baseline to 6 months
Change in systolic blood pressure (mm/Hg) for subjects in each study arm
Evaluate cardiovascular risk factor using systolic blood pressure-6 months
Time frame: Baseline to 12 months
Change in body weight (kg) for subjects in each study arm
Evaluate cardiovascular risk factor using Body weight-6 months
Time frame: Baseline to 6 months
Change in body weight (kg) for subjects in each study arm
Evaluate cardiovascular risk factor using Body weight-12 months
Time frame: Baseline to 12 months
Number of hypoglycemic episodes occurring in subjects in each study arm
Evaluate the frequency of hypoglycemia-6 months
Time frame: Baseline to 6 months
Number of hypoglycemic episodes occurring in subjects in each study arm
Evaluate the frequency of hypoglycemia-12 months
Time frame: Baseline to 12 months
Cost (dollars) of health care for subjects in each study arm
Cost of office visits, emergency room visits, hospital admissions, medication costs
Time frame: Baseline to 12 months
Reduction in the total number of medications required for subjects in each study arm
Reduction in medication requirements
Time frame: Baseline to 12 months
Change in the subject's overall score on the Diabetes Distress Scale in each study arm
Evaluate quality of life ratings using the Diabetes Distress Scale-6 months
Time frame: Baseline to 6 months
Change in the subject's overall score on the Diabetes Distress Scale in each study arm
Evaluate quality of life ratings using the Diabetes Distress Scale-12 months
Time frame: Baseline to 12 months
Change in the subject's T-Score on the SPADE survey in each study arm
Evaluate quality of life ratings using the general quality of life instrument (SPADE)-6 months
Time frame: Baseline to 6 months
Change in the subject's T-Score on the SPADE survey in each study arm
Evaluate quality of life ratings using the general quality of life instrument (SPADE)-12 months
Time frame: Baseline to 12 months
Change in the subject's score on the Medical Symptom Questionnaire (MSQ) in each study arm
Evaluate quality of life ratings using the Medical Symptom Questionnaire (MSQ)-6 months
Time frame: Baseline to 6 months
Change in the subject's score on the Medical Symptom Questionnaire (MSQ) in each study arm
Evaluate quality of life ratings using the Medical Symptom Questionnaire (MSQ)-12 months
Time frame: Baseline to 12 months
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