B=No Breakfast for Insulin Resistance

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Montefiore Medical Center of Albert Einstein College of Medicine, Bronx, NY
Insulin Resistance
B=No Breakfast - Other
Eligibility
< 65
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether skipping breakfast or eating breakfast has an effect on cognitive performance and the hormones responsible for glucose homeostasis in lean and obese adolescent males.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether B=No Breakfast will improve 7 primary outcomes in patients with Insulin Resistance. Measurement will happen over the course of 0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient.

Week 1
The measurement of C-peptide will be steady during the breakfast study visit
The measurement of CTET will be better during the breakfast study visit
The measurement of free fatty acids will be steady during the breakfast study visit
The measurement of glucagon will be steady during the breakfast study visit
The measurement of glucagon-like peptide will be steady during the breakfast study visit
The measurement of glucose will be euglycemic during the breakfast study visit
The measurement of insulin will be steady during the breakfast study visit

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Lean males
1 of 2
Obese males
1 of 2
Experimental Treatment

This trial requires 24 total participants across 2 different treatment groups

This trial involves 2 different treatments. B=No Breakfast is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Lean malesThis is a randomized, two-period, cross over design with the intervention of consuming breakfast versus fasting for breakfast to study the effects on hormone responses and cognitive function using CTET in lean and obese male adolescents. These two study groups will be randomized to one of two orders:: (A,B) or (B,A) where A = Yes breakfast and B=No breakfast
Obese malesThis is a randomized, two-period, cross over design with the intervention of consuming breakfast versus fasting for breakfast to study the effects on hormone responses and cognitive function using CTET in lean and obese male adolescents. These two study groups will be randomized to one of two orders:: (A,B) or (B,A) where A = Yes breakfast and B=No breakfast

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0min to 420 min during both during the treatment and control visits over the one year study period. each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 0min to 420 min during both during the treatment and control visits over the one year study period. each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient for reporting.

Closest Location

Montefiore Medical Center of Albert Einstein College of Medicine - Bronx, NY

Eligibility Criteria

This trial is for male patients aged 65 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The person does not have a history of neurological or psychiatric conditions, including major depressive disorder and attention deficit disorder. show original
A person's vision is measured by how well they can see objects from a certain distance show original
Healthy males
BMI greater than or equal to 30 A person with a BMI over 30 is considered obese. show original
This means that the person's hemoglobin A1C level is 5.6% or less. show original
The hemoglobin level is 12g/dL or greater. show original
Normal hearing

Patient Q&A Section

Can insulin resistance be cured?

"Insulin resistance cannot be cured and cannot be an exclusive cause of diabetes or other dysmetabolic (metabolic) disorders. Treating metabolic disorders such as insulin resistance or diabetes in isolation can often worsen the metabolic and/or cardiovascular consequences of the condition." - Anonymous Online Contributor

Unverified Answer

What causes insulin resistance?

"Insulin resistance occurs in about a quarter of people without any personal risk factors for Type 2 Diabetes. It may be that genes play a role. More research is now needed to clarify its mechanism and to identify children at risk before development of Type 2 diabetes." - Anonymous Online Contributor

Unverified Answer

What are common treatments for insulin resistance?

"The most common treatment for non-diabetic insulin resistance, including cases with insulin resistance, is exercise combined with caloric restriction, weight loss and a change in diet pattern. These therapies do not decrease the risk for developing type 2 diabetes or cardiovascular diseases." - Anonymous Online Contributor

Unverified Answer

How many people get insulin resistance a year in the United States?

"It is estimated that one of every five, twenty-three of every eight persons, and forty-five thousand women in the United States are insulin resistant. A disproportionate percentage of these people are black or Hispanic." - Anonymous Online Contributor

Unverified Answer

What is insulin resistance?

"Insulin resistance (IR) is a condition marked by a marked increase in plasma glucose in the setting of a normal or high plasma insulin response to a glucose load. In people with IR insulin secretion decreases and plasma glucose tolerance may be low, even if plasma insulin levels remain within normal limits.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of insulin resistance?

"The signs of insulin resistance include high body mass index, lack of oral hypoglycemia, poor glucose tolerance, high glycemic indices, high total and free triglyceride." - Anonymous Online Contributor

Unverified Answer

Is b=no breakfast typically used in combination with any other treatments?

"In daily practice, an elevated fasting insulin level was the most important predictive parameter for the likelihood of an individual having a b=no breakfast. Fasting insulin was also a significant predictor for the number of hypoglycaemic episodes during the year following an elevated fasting insulin level." - Anonymous Online Contributor

Unverified Answer

What is b=no breakfast?

"For every 3 hours of sleep in an adults age 70-80 years old, a 0.5 kg decrease in body weight is observed. Furthermore, this is even more evident in men. After one meal or a fat-free breakfast, a 2.8% extra weight loss is noticed even in women. If the main hypothesis is true, one would expect obese men to lose less weight. However, in this cohort, overweight status is not associated with higher body fat." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for insulin resistance?

"The majority of clinical trials for insulin resistance and cardiometabolic disease have poor or no methodology. Clinical trials with poor study design will not demonstrate differences between treatment groups. Randomized clinical trials are thus advised to be conducted for cardio-metabolic disease, insulin resistance, end-stage disease with comorbidities, and other related conditions. However, the importance of clinical trials for insulin resistance, especially those with good-quality design, cannot be underestimated." - Anonymous Online Contributor

Unverified Answer

How does b=no breakfast work?

"The increase in insulin resistance after consuming a b=no breakfast is consistent with earlier research on mixed meals. This increase is also evident when consuming a high-fiber bread product." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in b=no breakfast for therapeutic use?

"At the same time, it should remember that new indications have no effect on the development of drug interactions. Drug interactions are only a factor to limit." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of b=no breakfast?

"'Side effect' can include many different aspects of the patient's life, with no single'side effect' accounting for many problems. While some side effects affect more than one other thing, some side effects can affect more than one part of a person's life." - 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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