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

NCT ID: NCT04558827

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-01-24

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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Carb / Time Restricted Feeding

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).

Group Type: EXPERIMENTAL

Low Carbohydrate Diet

Intervention Type: OTHER

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

Time Restricted Feeding

Intervention Type: OTHER

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

Interventions

Low Carbohydrate Diet

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

Intervention Type: OTHER

Time Restricted Feeding

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

Intervention Type: OTHER

Other Intervention Names

Intermittent Fasting

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Feldstein, MD

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

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

Countries

United States

Other Identifiers

A534253

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/GEN INT MD

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 4/20/2020

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0140

Identifier Type: -

Identifier Source: org_study_id