NCT04558827

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

Feasibility Study of a Low-Carb/Time-restricted Feeding Protocol in Insulin-Using Type 2 Diabetics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
OTHER	Low Carbohydrate Diet	Dietary choices are counseled to come primarily from lean meats, eggs, nuts, seeds, vegetables and berries.
OTHER	Time Restricted Feeding	Participants will be asked to have 2 meals within an 8 hour period, preferably before 2pm.

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-01-24
• Completion: 2022-01-24
• First posted: 2020-09-22
• Last updated: 2022-03-14

Locations

3 sites across 1 country: United States