Low-Carb/Time-restricted Feeding Protocol in Insulin-Using Type 2 Diabetics

University of Wisconsin, Madison20 enrolled

Overview

The current paradigm of Type 2 Diabetes treatment relies heavily on expensive pharmacotherapy even though lifestyle factors are at the root of the condition. This study is designed to assess the feasibility of a low carbohydrate diet coupled with a time restricted feeding intervention to improve participant sensitivity, reducing their need for insulin. 20 participants will be invited to enroll from the 20 S Park St Clinic in Madison, WI and remain on study for up to 6 months.

The investigators will perform a prospective cohort study of 20 insulin-using Type 2 diabetics who have primary care providers at 20 S Park St Clinic. Participants will be recruited from the Internal Medicine practices at the clinic. The subjects will meet with Dr. Zimmermann (Study Clinician) to review time restricted feeding and low-carbohydrate diets as well as a strategy for decreasing insulin doses. Calls from Dr. Zimmermann's clinic nurse will occur daily until blood glucose levels stabilize to manage insulin decrease. Participants will complete monthly logs of food intake times and meet with a dietician twice during the 6-month study. Diabetes medication use will be reviewed, and hemoglobin A1c will be measured, at baseline and at 3 and 6 months. The participants' non-diabetic medical care will continue to be managed through their primary care physicians (PCPs). Specific Aims: * Demonstrate feasibility of the low carbohydrate/time restricted feeding (LC/TRF) protocol * Feasibility will be assessed based on participant compliance with time-restricted feeding and recommended carbohydrate intake, clinician time and clinic resources * Determine effectiveness of the LC/TRF protocol on diabetes care and quality of life * Effectiveness on diabetes care will be evaluated using changes in A1c, insulin use, BMI, patient quality of life, and adverse events including hypoglycemia.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type2 Diabetes

Interventions

Low Carbohydrate DietOTHER

Dietary choices are counseled to come primarily from lean meats, eggs, nuts, seeds, vegetables and berries.

Time Restricted FeedingOTHER

Participants will be asked to have 2 meals within an 8 hour period, preferably before 2pm.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient of a primary care provider at 20 S Park Internal Medicine Clinic * Insulin using type 2 diabetic * Using glargine or detemir insulin for basal insulin dosing * Self-administering insulin * Hemoglobin A1c 7-10%. * Stable diabetes regimen for \>3 months * Demonstrated reliability with glucose monitoring, A1c checks * BMI 25-35 Exclusion Criteria: * History consistent with type 1 diabetes * Using concentrated insulin (U200 or U300) * Living in a skilled nursing facility * Unwilling or unable to do frequent (3x daily) blood glucose checks * eGFR (estimated glomerular filtration rate) \< 30 mL/min per 1.73 m2 * Currently on steroids or warfarin * Hospitalized within 3 months * Symptomatic heart failure * Weight Loss \>10% in last six months * History of organ transplantation * Pregnant/trying to become pregnant/breast feeding

Locations (3)

UW Health Union Corners Clinic

Madison, Wisconsin, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

UW Health West Clinic

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Effectiveness of Intervention: Changes in Hemoglobin A1c

Changes in A1c will be measured at baseline, 3 and 6 month MD visits. Data will be extracted from HealthLink by chart review. Comparisons will be made between post-intervention A1c scores and baseline scores, at 1 month and at 3 months using paired t-tests to detect whether patients experienced a positive outcome.

Time frame: baseline, 3 months, 6 months

Effectiveness of Intervention: Changes in Insulin Dosage

Changes in insulin dosage will be measured at baseline, 3 and 6 month MD visits. Data will be extracted from HealthLink by chart review.

Time frame: baseline, 3 months, 6 months

Secondary Outcomes

Participant Satisfaction

Participant satisfaction with the protocol will be assessed at 3 and 6 months. This will include questions about difficulty, barriers to implementation, and impact on family. Quantitative and qualitative analysis will be performed to determine barriers and facilitators to maintaining TRF and low carbohydrate diet. Semi-structured phone interviews will be performed with 10 of the patients (5 who maintained the LC/TRF protocol and 5 who did not) to understand the impact of the TRF and low carbohydrate diet on their daily lives and determine barriers and facilitators. Interviews will be transcribed and thematic analysis will be performed.

Time frame: 3 months, 6 months

Change in Appraisal of Diabetes Scale (ADS) Score

Participant quality of life (QoL) will be assessed at baseline, 3 and 6 months with the Appraisal of Diabetes Scale (ADS). The ADS is a validated tool to measure patients' appraisal of how well they can care for their diabetes and its impact on their life. It is a 7-item survey with each question scored on a likert scale (1-5) for a total range of possible scores 7-35, where lower scores indicate better QoL. Statistical analysis will be performed using paired t-tests or non-parametric methods based on distribution to evaluate ADS changes over time.

Data from ClinicalTrials.gov

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