Clinical trial NCT04558827: Low-Carb/Time-restricted Feeding Protocol in Insulin-Using Type 2 Diabetics
Official title: Feasibility Study of a Low-Carb/Time-restricted Feeding Protocol in Insulin-Using Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: low carbohydrate diet
time restricted feeding
insulin sensitivity
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective cohort study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of Intervention: Changes in Hemoglobin A1c
timeFrame: baseline, 3 months, 6 months
measure: Effectiveness of Intervention: Changes in Insulin Dosage
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Participant Satisfaction
timeFrame: 3 months, 6 months
measure: Change in Appraisal of Diabetes Scale (ADS) Score
timeFrame: baseline, 3 months, 6 months
measure: Clinic-level feasibility: Average Hours of Support Time per Participant
timeFrame: up to 6 months
measure: Effectiveness of Intervention: Changes in BMI
timeFrame: baseline, 3 months, 6 months
measure: Feasibility: Percent of days where food was eaten within the target timeframe
timeFrame: up to 6 months
measure: Feasibility: Average Daily Calories
timeFrame: up to 6 months
measure: Feasibility: Percent of day compliant with Carbohydrate target
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health Union Corners Clinic
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Madison
country: United States
facility: UW Health West Clinic
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: David Feldstein, MD
role: PRINCIPAL_INVESTIGATOR
References: