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

University of Wisconsin (UW)

Status: Completed

Conditions: Type2 Diabetes

Treatments: Other: Time Restricted Feeding; Other: Low Carbohydrate Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04558827

SMPH/MEDICINE/GEN INT MD (Other Identifier)

A534253 (Other Identifier)

Protocol Version 4/20/2020 (Other Identifier)

2020-0140

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Low Carb / Time Restricted Feeding

Experimental group

Description:

Participants will eat a low carbohydrate diet (30-60 grams) in a time restricted feeding window (2 meals within 8 hours) daily for the duration of the study (6 months).

Treatment:

Other: Time Restricted Feeding

Other: Low Carbohydrate Diet