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

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

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.

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.

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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note