Time Limited Eating for Type 1 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Hospital Los Angeles, Los Angeles, CA
Type 1 Diabetes Mellitus+2 More
Time Limited Eating - Other
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

Time Limited Eating in Type 1 Diabetes

See full description

Eligible Conditions

  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Type 1 Diabetes Mellitus

Study Objectives

This trial is evaluating whether Time Limited Eating will improve 6 primary outcomes and 9 secondary outcomes in patients with Type 1 Diabetes Mellitus. Measurement will happen over the course of At end of study (at 9 weeks).

Week 9
Acceptability and feasibility of intervention, as indicated by the "Intervention Satisfaction Survey"
Baseline and 12 weeks
Change in beta-cell function at 12 weeks, as indicated by mixed meal tolerance test with C-peptide levels
Physical activity frequency, as indicated by Physical Activity Questionnaire
Quality of life, as indicated by Pediatric Quality of Life Inventory
Baseline and 9 weeks
Anxiety, as indicated by Neuro-QOL-Anxiety-Short Form
Binge Eating, as indicated by Binge Eating Disorder Screener
Change in β-cell function at 9 weeks, as indicated by mixed meal tolerance test with C-peptide levels
Impact on activities of daily living, as indicated by Munich Chronotype Questionnaire (MCTQ)
Quality of life, as indicated by Pediatric Quality of Life Inventory (PedsQL), Diabetes Module
Stress level, as indicated by Perceived Stress Scale
Week 12
Dietary patterns, as indicated by Nutrient Data System Recall (NDSR)
Baseline, 9 weeks
Dietary patterns, as indicated by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
Week 12
Change in glycemic control at 12 weeks, as indicated by continuous glucose monitoring (percent time in range), and HbA1c
Up to 9 weeks
Safety, as indicated by hypoglycemia
Week 9
Change in glycemic control at 9 weeks, as indicated by continuous glucose monitoring (percent time in range), and HbA1c

Trial Safety

Safety Progress

1 of 3

Other trials for Type 1 Diabetes Mellitus

Trial Design

2 Treatment Groups

Control - Standard Care
1 of 2
Intervention - Time Limited Eating
1 of 2
Active Control
Experimental Treatment

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Time Limited Eating is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention - Time Limited Eating
Other
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
Control - Standard Careincludes a minimum 12-hour feeding window for 7 days per week no caloric restriction will be used will wear a continuous glucose monitor

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 weeks; hba1c: baseline and 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 weeks; hba1c: baseline and 12 weeks for reporting.

Who is running the study

Principal Investigator
j. r.
jennifer raymond, Chief of the Division of Endocrinology, Principal Investigator
Children's Hospital Los Angeles

Closest Location

Children's Hospital Los Angeles - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What is type 1 diabetes mellitus?

"The present study demonstrates an association between T1DM and the prevalence of diabetic retinopathy. The presence of T1DM may be an independent risk factor for the development of diabetic retinopathy in T2DM patients in the first 5 yr of their diabetes duration." - Anonymous Online Contributor

Unverified Answer

Can type 1 diabetes mellitus be cured?

"With appropriate treatment and surveillance, most individuals can live a normal life and have a normal life expectancy, but people with IDDM do not have the same ability to maintain this quality of life." - Anonymous Online Contributor

Unverified Answer

What are common treatments for type 1 diabetes mellitus?

"There are five therapies to treat [type 1 diabetes](https://www.withpower.com/clinical-trials/type-1-diabetes) mellitus: insulin injection; insulin pump infusion; insulin therapy; [gliclazide (GlucaTap)]; and [glargine (Lantus)]. There are also a number of oral medications; however, most type 1 diabetes medications taken by patients are [insulin] and [blood sugar] test medications and [hypoglycemics(tablets)(Listerine)]. Most diabetes medications are used to keep the blood sugar down in the patient with type 1 diabetes. Clinical trials are very useful because drug companies manufacture clinical tests to show the effectiveness of a type 1 diabetes medication in people as new evidence. Most type 1 diabetes medications are injected [in hospital]." - Anonymous Online Contributor

Unverified Answer

What causes type 1 diabetes mellitus?

"Recent studies on the role of T1DM autoimmunity and genetics suggest new insights into the etiology of T1DM. There is some evidence for T1DM autoimmunity as a causative factor that may lead to the development of clinically overt diabetes by either the direct or indirect activation of islet autoimmunity." - Anonymous Online Contributor

Unverified Answer

What are the signs of type 1 diabetes mellitus?

"In order to recognize clinical DM, early detection of diabetes-associated symptoms and early evaluation in the diabetic population are essential. To recognize these symptoms early in patients with type 1 diabetes, routine visits to an endocrinologist are indicated at least every other year." - Anonymous Online Contributor

Unverified Answer

How many people get type 1 diabetes mellitus a year in the United States?

"Type 1 diabetes is rare. Around 13,500 people will develop type 1 diabetes mellitus in the United States per year while 80 million will receive a diagnosis of type 2 diabetes. The yearly risk of progression from type 1 to type 2 diabetes is 0.02%." - Anonymous Online Contributor

Unverified Answer

What is time limited eating?

"The presence of the TT genotype of the FTO gene rs8042523 was associated with more fast food consumption and greater BMI. These associations persisted even beyond adjusting for sex and ethnicity. A single day of fast food consumption appeared to lead to weight gain for a longer-term period of one week regardless of race/ethnicity." - Anonymous Online Contributor

Unverified Answer

Does time limited eating improve quality of life for those with type 1 diabetes mellitus?

"Findings from a recent study from this prospective longitudinal study on the effect of time-limited eating and exercise on HRQoL of persons with type 1 diabetes indicated that improvements in HRQoL may not be solely due to weight control." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of time limited eating?

"Side effects reported within a small percentage of the group, which is very similar to the reported side effects reported in a big percentage of the population, were vomiting (2%) and vomiting accompanied by abdominal pain (1.5%). These were mild and transient side effects which tended to affect most patients within the first day after eating. Therefore, they are not necessarily serious. The only side effect which was very common (7%) was fatigue. This may be due to the small number of patients who had some other symptom that caused fatigue, or the way that time limited eating is assessed. Therefore, we should try to give it a higher importance, and more careful care will be necessary in general." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets type 1 diabetes mellitus?

"About 1 in 50 children develop [type 1 diabetes](https://www.withpower.com/clinical-trials/type-1-diabetes), usually in early childhood. A high proportion of children develop type 1 diabetes outside of those with family history of diabetes or those without known risk factors for diabetes." - Anonymous Online Contributor

Unverified Answer

Is time limited eating safe for people?

"Findings from a recent study show that the current policy for treating T1DM in England and Wales does not meet the key aim of achieving a diet that reduces the risk of progression to microvascular complications, and identifies the need for a more explicit, comprehensive and evidence-based policy with clearly stated objectives for those people who have T1DM." - Anonymous Online Contributor

Unverified Answer

How serious can type 1 diabetes mellitus be?

"Results from a recent paper of this study imply that patients with T1D have a high frequency of severe autonomic dysfunction, even with good glycaemic control and a recent onset of disease. It is therefore of utmost importance that glycaemic parameters are kept under control by regular insulin injection. Results from a recent paper suggest that regular insulin injection should be started in T1D patients as early as the time of diagnosis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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