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Type 1 DiabetesTLET1DNCT05031429

Time Limited Eating in Type 1 Diabetes

A study testing Time Limited Eating in people with Type 1 Diabetes, run by Children's Hospital Los Angeles at 1 site 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

This study is a randomized-control pilot study that aims to evaluate Time Limited Eating (TLE) in the pediatric T1D population, implemented within the first six months after diagnosis. Read more about this study

Who is it for?
Ages 12 to 25 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Time Limited Eating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Jan 2022to 30 Jun 2023
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 12 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • includes age of 12-25 years
  • T1D diagnosed within 6 months
  • at least one positive pancreatic antibody including glutamic acid decarboxylase (GAD) antibody, islet tyrosine phosphatase 2 (IA2) antibody, or insulin antibody
  • can be on either insulin injections or insulin pump
  • can be of any BMI status
  • can speak any language

Who cannot join

  • negative pancreatic antibodies
  • unwillingness to wear a CGM

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

Other trials in United States

About this study

Official title: Time Limited Eating in New-Onset Type 1 Diabetes: Feasibility, Acceptability, and Effect on β-cell Function

This study is a randomized-control pilot study that aims to evaluate Time Limited Eating (TLE) in the pediatric T1D population, implemented within the first six months after diagnosis. This period is characterized by residual β-cell function, during which TLE may have the ability to preserve and improve β-cell activity, indicated by increased C-peptide production. The investigators aim to assess the feasibility, acceptability, and safety of TLE in the pediatric T1D population, as well as to investigate the impact of TLE on β-cell function, insulin sensitivity, and glycemic control.

Read the detailed description

This will be a two-armed study with an intervention and control group. Feasibility and acceptability will be assessed by using questionnaires. Safety will be indicated by hypoglycemia occurrence. β-cell function and insulin sensitivity will be evaluated using mixed meal tolerance test with C-peptide and glucose levels. Glycemic control will be indicated by continuous glucose monitor (CGM). Block randomization will be utilized to ensure the groups are balanced in terms of BMI. The study period will be 9 weeks in duration, including a week-long run-in period and an 8-week intervention period. There will be two in-person study visits at week 0 and week 9. Anthropometrics including weight, height, and pubertal status will be evaluated at these times.

Group 1- Standard Care (control)

  • includes a minimum 12-hour feeding window for 7 days per week
  • no caloric restriction will be used
  • will wear a continuous glucose monitor

Group 2 - TLE (intervention)

  • includes an 8-hour feed/16-hour fast for 7 days per week
  • will be instructed to consume all of their calories in the afternoon/evening period
  • can consume non-caloric beverages (water, tea, coffee) during the fasting period
  • will wear a continuous glucose monitor
  • no caloric restriction will be used
Conditions
Type 1 Diabetes
Being tested
Time Limited Eating
Keywords
Type 1 Diabetes, Time Limited Eating, β-cell
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • Time Limited EatingOther

    Includes an 8-hour feed/16-hour fast for 7 days per week, with consumption of all of calories in the afternoon/evening. Can consume non-caloric beverages (water, tea, coffee) during the fasting period. No caloric restriction will be used.

Study groups in NCT05031429
Study groupRoleWhat they receive
Control - Standard CareNo intervention* includes a minimum 12-hour feeding window for 7 days per week * no caloric restriction will be used * will wear a continuous glucose monitor
Intervention - Time Limited EatingExperimental* includes an 8-hour feed/16-hour fast for 7 days per week * will be instructed to consume all of their calories in the afternoon/evening period * can consume non-caloric beverages (water, tea, coffee) during the fasting period * will wear a continuous glucose monitor * no caloric restriction will be used
Receives: Other: Time Limited Eating

What is being measured

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

  1. Acceptability and feasibility of intervention, as indicated by the "Intervention Satisfaction Survey"

    Likert scale "Agree strongly" is 1, "Agree" is 2, "Neutral" is 3, "Disagree" is 4, and "Disagree strongly" is 5. Lower scores indicate more satisfaction, higher scores indicate low satisfaction.

    Measured: At end of study (at 9 weeks)

  2. Change in β-cell function at 9 weeks, as indicated by mixed meal tolerance test with C-peptide levels

    C-peptide and glucose levels will be performed at baseline and 60-, 90-, and 120-minutes post-meal. Baseline plasma C-peptide concentration divided by the baseline plasma glucose concentration will be calculated as a pragmatic marker of β-cell function. The area under the stimulated C-peptide curve will then be calculated, which will be the primary outcome examined.

    Measured: Baseline and 9 weeks

  3. Change in glycemic control at 9 weeks, as indicated by continuous glucose monitoring (percent time in range), and HbA1c

    Continuous glucose monitors will be worn for duration of the study, glycemic control will be evaluated using percent time in range. HbA1c will reflect glycemic control over time.

    Measured: Up to 9 weeks; HbA1c: Baseline and 9 weeks

  4. Safety, as indicated by hypoglycemia

    Hypoglycemia will be defined as blood sugar < 70 mg/dL on continuous glucose monitor. Frequency and severity of hypoglycemia will be used to assess safety of intervention.

    Measured: Up to 9 weeks

Secondary outcomes (6)

  1. Dietary patterns, as indicated by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)

    24-hour dietary recall, ~30 minutes to complete.

    Measured: Baseline, 9 weeks

  2. Quality of life, as indicated by Pediatric Quality of Life Inventory (PedsQL), Diabetes Module

    Likert scale "Never" is 0, "Almost Never" is 1, "Sometimes" is 2, "Often" is 3, and "Almost Always" is 4

    Measured: Baseline and 9 weeks

  3. Stress level, as indicated by Perceived Stress Scale

    Likert scale "Never" is 0, "Almost Never" is 1, "Sometimes" is 2, "Fairly Often" is 3, and "Very Often" is 4

    Measured: Baseline and 9 weeks

  4. Binge Eating, as indicated by Binge Eating Disorder Screener

    Likert scale "Never or rarely" is 0, "Sometimes" is 1, "Often" is 2, "Always" is 3. Additionally, two yes or no questions.

    Measured: Baseline and 9 weeks

  5. Anxiety, as indicated by Neuro-QOL-Anxiety-Short Form

    Likert scale "Never" is 1, "Rarely" is 2, "Sometimes" is 3, "Often" is 4, "Always" is 5

    Measured: Baseline and 9 weeks

  6. Impact on activities of daily living, as indicated by Munich Chronotype Questionnaire (MCTQ)

    Assessment of sleep schedule, school schedule, time spent outdoors. Multiple choice and open-ended questions.

    Measured: Baseline and 9 weeks

Timeline

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

  1. First posted1 Sep 2021
  2. Study start1 Jan 2022
  3. Primary completion13 Jun 2023
  4. Study completion30 Jun 2023

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05031429
Sponsor's protocol ID
CHLA-21-00269
Acronym
TLET1D
Status last verified
Aug 2023
First submitted
1 Aug 2021
Last updated
16 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gabel K, Varady KA. Feasibility of Time-Restricted Eating. Obesity (Silver Spring). 2020 May;28(5):860. doi: 10.1002/oby.22785. No abstract available.

    PubMed 32320147

  • Gabel K, Hoddy KK, Varady KA. Safety of 8-h time restricted feeding in adults with obesity. Appl Physiol Nutr Metab. 2019 Jan;44(1):107-109. doi: 10.1139/apnm-2018-0389. Epub 2018 Sep 14.

    PubMed 30216730

  • Cienfuegos S, Gabel K, Kalam F, Ezpeleta M, Wiseman E, Pavlou V, Lin S, Oliveira ML, Varady KA. Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cell Metab. 2020 Sep 1;32(3):366-378.e3. doi: 10.1016/j.cmet.2020.06.018. Epub 2020 Jul 15.

    PubMed 32673591

  • Wilkinson MJ, Manoogian ENC, Zadourian A, Lo H, Fakhouri S, Shoghi A, Wang X, Fleischer JG, Navlakha S, Panda S, Taub PR. Ten-Hour Time-Restricted Eating Reduces Weight, Blood Pressure, and Atherogenic Lipids in Patients with Metabolic Syndrome. Cell Metab. 2020 Jan 7;31(1):92-104.e5. doi: 10.1016/j.cmet.2019.11.004. Epub 2019 Dec 5.

    PubMed 31813824

  • Taylor R. Type 2 diabetes: etiology and reversibility. Diabetes Care. 2013 Apr;36(4):1047-55. doi: 10.2337/dc12-1805. No abstract available.

    PubMed 23520370

  • Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.

    PubMed 29754952

  • Hutchison AT, Regmi P, Manoogian ENC, Fleischer JG, Wittert GA, Panda S, Heilbronn LK. Time-Restricted Feeding Improves Glucose Tolerance in Men at Risk for Type 2 Diabetes: A Randomized Crossover Trial. Obesity (Silver Spring). 2019 May;27(5):724-732. doi: 10.1002/oby.22449. Epub 2019 Apr 19.

    PubMed 31002478

  • Chow LS, Manoogian ENC, Alvear A, Fleischer JG, Thor H, Dietsche K, Wang Q, Hodges JS, Esch N, Malaeb S, Harindhanavudhi T, Nair KS, Panda S, Mashek DG. Time-Restricted Eating Effects on Body Composition and Metabolic Measures in Humans who are Overweight: A Feasibility Study. Obesity (Silver Spring). 2020 May;28(5):860-869. doi: 10.1002/oby.22756. Epub 2020 Apr 9.

    PubMed 32270927

  • Jamshed H, Beyl RA, Della Manna DL, Yang ES, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves 24-Hour Glucose Levels and Affects Markers of the Circadian Clock, Aging, and Autophagy in Humans. Nutrients. 2019 May 30;11(6):1234. doi: 10.3390/nu11061234.

    PubMed 31151228

  • Center for Disease and Control Prevention. Incidence of newly diagnosed diabetes. https://www.cdc.gov/diabetes/data/statistics-report/newly-diagnosed-diabetes.html. 2020; Accessed April 25, 2021.

  • Bingley PJ, Wherrett DK, Shultz A, Rafkin LE, Atkinson MA, Greenbaum CJ. Type 1 Diabetes TrialNet: A Multifaceted Approach to Bringing Disease-Modifying Therapy to Clinical Use in Type 1 Diabetes. Diabetes Care. 2018 Apr;41(4):653-661. doi: 10.2337/dc17-0806.

    PubMed 29559451

  • Lennerz BS, Barton A, Bernstein RK, Dikeman RD, Diulus C, Hallberg S, Rhodes ET, Ebbeling CB, Westman EC, Yancy WS Jr, Ludwig DS. Management of Type 1 Diabetes With a Very Low-Carbohydrate Diet. Pediatrics. 2018 Jun;141(6):e20173349. doi: 10.1542/peds.2017-3349. Epub 2018 May 7.

    PubMed 29735574

  • de Souza Bosco Paiva C, Lima MHM. Introducing a very low carbohydrate diet for a child with type 1 diabetes. Br J Nurs. 2019 Aug 8;28(15):1015-1019. doi: 10.12968/bjon.2019.28.15.1015.

    PubMed 31393762

  • Calabrese CM, Valentini A, Calabrese G. Gut Microbiota and Type 1 Diabetes Mellitus: The Effect of Mediterranean Diet. Front Nutr. 2021 Jan 13;7:612773. doi: 10.3389/fnut.2020.612773. eCollection 2020.

    PubMed 33521039

  • Vidmar AP, Goran MI, Naguib M, Fink C, Wee CP, Hegedus E, Lopez K, Gonzalez J, Raymond JK. Time limited eating in adolescents with obesity (time LEAd): Study protocol. Contemp Clin Trials. 2020 Aug;95:106082. doi: 10.1016/j.cct.2020.106082. Epub 2020 Jul 16.

    PubMed 32682994

Questions about this trial

What is this clinical trial studying?

A study testing Time Limited Eating in people with Type 1 Diabetes, run by Children's Hospital Los Angeles at 1 site 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 6 inclusion and 2 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 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Acceptability and feasibility of intervention, as indicated by the "Intervention Satisfaction Survey" (time frame: At end of study (at 9 weeks)). The study lists 4 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 NCT05031429, which also lists 36 linked publications.

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 16 Aug 2023.

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Time Limited Eating in Type 1 Diabetes (NCT05031429) | AzTrials