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

  • End date
    Dec 20, 2021
  • participants needed
  • sponsor
    University of Wisconsin, Madison
Updated on 20 June 2021


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.

Condition Type2 Diabetes
Treatment Low Carbohydrate Diet, Time restricted feeding
Clinical Study IdentifierNCT04558827
SponsorUniversity of Wisconsin, Madison
Last Modified on20 June 2021


Yes No Not Sure

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
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