NCT04558827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2022

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

September 9, 2020

Last Update Submit

March 11, 2022

Conditions

Type2 Diabetes

Keywords

low carbohydrate diettime restricted feedinginsulin sensitivity

Outcome Measures

Primary Outcomes (2)

  • Effectiveness of Intervention: Changes in Hemoglobin A1c

    Changes in A1c will be measured at baseline, 3 and 6 month MD visits. Data will be extracted from HealthLink by chart review. Comparisons will be made between post-intervention A1c scores and baseline scores, at 1 month and at 3 months using paired t-tests to detect whether patients experienced a positive outcome.

    baseline, 3 months, 6 months

  • Effectiveness of Intervention: Changes in Insulin Dosage

    Changes in insulin dosage will be measured at baseline, 3 and 6 month MD visits. Data will be extracted from HealthLink by chart review.

    baseline, 3 months, 6 months

Secondary Outcomes (7)

  • Participant Satisfaction

    3 months, 6 months

  • Change in Appraisal of Diabetes Scale (ADS) Score

    baseline, 3 months, 6 months

  • Clinic-level feasibility: Average Hours of Support Time per Participant

    up to 6 months

  • Effectiveness of Intervention: Changes in BMI

    baseline, 3 months, 6 months

  • Feasibility: Percent of days where food was eaten within the target timeframe

    up to 6 months

  • +2 more secondary outcomes

Study Arms (1)

Low Carb / Time Restricted Feeding

EXPERIMENTAL

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).

Other: Low Carbohydrate DietOther: Time Restricted Feeding

Interventions

Low Carbohydrate DietOTHER

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

Low Carb / Time Restricted Feeding
Time Restricted FeedingOTHER

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

Also known as: Intermittent Fasting
Low Carb / Time Restricted Feeding

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UW Health Union Corners Clinic

Madison, Wisconsin, 53704, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53705, United States

Location

UW Health West Clinic

Madison, Wisconsin, 53717, United States

Location

MeSH Terms

Conditions

Intermittent FastingInsulin Resistance

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • David Feldstein, MD

    UW School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 22, 2020

Study Start

February 1, 2021

Primary Completion

January 24, 2022

Study Completion

January 24, 2022

Last Updated

March 14, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)