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Type2 DiabetesNCT04558827

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

A study testing Low Carbohydrate Diet and Time Restricted Feeding in people with Type2 Diabetes, run by University of Wisconsin, Madison at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type2 Diabetes
What is being tested?
Low Carbohydrate Diet and Time Restricted Feeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesUnited States
Study dates
1 Feb 2021to 24 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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 locations and contacts

3 sites in 1 country.

United States3 sites

  • UW Health Union Corners Clinic

    Madison, Wisconsin, 53704

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53705

  • UW Health West Clinic

    Madison, Wisconsin, 53717

Other trials in United States

About this study

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

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.

Read the 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
Being tested
Low Carbohydrate Diet, Time Restricted Feeding
Keywords
low carbohydrate diet, time restricted feeding, insulin sensitivity
Medical subject headings
Intermittent Fasting, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Carbohydrate DietOther

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

  • Time Restricted FeedingOther

    Also called Intermittent Fasting

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

Study groups in NCT04558827
Study groupRoleWhat they receive
Low Carb / Time Restricted FeedingExperimentalParticipants 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).
Receives: Other: Low Carbohydrate Diet; Other: Time Restricted Feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, 3 months, 6 months

  2. 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.

    Measured: baseline, 3 months, 6 months

Secondary outcomes (7)

  1. Participant Satisfaction

    Participant satisfaction with the protocol will be assessed at 3 and 6 months. This will include questions about difficulty, barriers to implementation, and impact on family. Quantitative and qualitative analysis will be performed to determine barriers and facilitators to maintaining TRF and low carbohydrate diet. Semi-structured phone interviews will be performed with 10 of the patients (5 who maintained the LC/TRF protocol and 5 who did not) to understand the impact of the TRF and low carbohydrate diet on their daily lives and determine barriers and facilitators. Interviews will be transcribed and thematic analysis will be performed.

    Measured: 3 months, 6 months

  2. Change in Appraisal of Diabetes Scale (ADS) Score

    Participant quality of life (QoL) will be assessed at baseline, 3 and 6 months with the Appraisal of Diabetes Scale (ADS). The ADS is a validated tool to measure patients' appraisal of how well they can care for their diabetes and its impact on their life. It is a 7-item survey with each question scored on a likert scale (1-5) for a total range of possible scores 7-35, where lower scores indicate better QoL. Statistical analysis will be performed using paired t-tests or non-parametric methods based on distribution to evaluate ADS changes over time.

    Measured: baseline, 3 months, 6 months

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

    MD and RD clinic time along with RN phone support will be logged with each encounter to provide a quantitative assessment of the resources required to implement this type of intervention on a clinic scale. Descriptive statistics with means and standard deviations per patient will be calculated for each class of health care provider.

    Measured: up to 6 months

  4. Effectiveness of Intervention: Changes in BMI

    Changes in BMI will be measured at baseline, 3 and 6 month MD visits. Data will be extracted from HealthLink by chart review. Weight and height will be combined to report BMI in kg/m^2.

    Measured: baseline, 3 months, 6 months

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

    Participant compliance with time-restricted feeding will be evaluated using monthly journals logging first and last food intake each day. The journals will be mailed to Dr. Zimmermann via pre-addressed/stamped security envelopes or brought to appointments. Time-restricted feeding compliance will be calculated using descriptive statistics to determine the % of days where all food was eaten within the target timeframe. Analysis will be done for all data available, data from participants with logs for >50% of days, and participants with logs for >75% of days.

    Measured: up to 6 months

  6. Feasibility: Average Daily Calories

    Participant compliance with recommended carbohydrate intake will be evaluated based on data from the registered dietitian (RD) dietary review. RD will calculate daily grams of carbohydrate and total calories. Compliance will be calculated with descriptive statistics for % of days compliant with <30g, 30-60g, >60g of carbohydrates as well as average daily calories.

    Measured: up to 6 months

  7. Feasibility: Percent of day compliant with Carbohydrate target

    Participant compliance with recommended carbohydrate intake will be evaluated based on data from the registered dietitian (RD) dietary review. RD will calculate daily grams of carbohydrate and total calories. Compliance will be calculated with descriptive statistics for % of days compliant with <30g, 30-60g, >60g of carbohydrates as well as average daily calories.

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2020
  2. Study start1 Feb 2021
  3. Primary completion24 Jan 2022
  4. Study completion24 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
prospective cohort study
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04558827
Sponsor's protocol ID
2020-0140
Other IDs
A534253, SMPH/MEDICINE/GEN INT MD, Protocol Version 4/20/2020
Status last verified
Mar 2022
First submitted
9 Sep 2020
Last updated
14 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Low Carbohydrate Diet and Time Restricted Feeding in people with Type2 Diabetes, run by University of Wisconsin, Madison at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of Intervention: Changes in Hemoglobin A1c (time frame: baseline, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04558827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022; AzTrials last refreshed its copy on 27 Oct 2026.

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