Exercise Intervention for Impaired Glucose Tolerance

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CA
Impaired Glucose Tolerance+6 More
Exercise Intervention - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether exercise and nicotinamide riboside can improve muscle health and insulin resistance in adult survivors of childhood cancer.

See full description

Eligible Conditions

  • Impaired Glucose Tolerance
  • Malignant Solid Neoplasms
  • Hematopoietic and Lymphoid Cell Neoplasm

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Exercise Intervention will improve 1 primary outcome in patients with Impaired Glucose Tolerance. Measurement will happen over the course of Up to 6 weeks.

Up to 6 weeks
Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm I (home exercise)
1 of 2
Arm II (home exercise, nicotinamide riboside)
1 of 2
Active Control
Experimental Treatment

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Exercise Intervention 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.

Arm II (home exercise, nicotinamide riboside)Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks.
Arm I (home exercise)
Other
Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinamide Riboside
2022
N/A
~80

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 weeks for reporting.

Closest Location

City of Hope Medical Center - Duarte, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
History of childhood cancer
History of prediabetes (HbA1c 5.7-6.4%)
In remission at time of enrollment
Time between completion of cancer-directed therapy and study entry: >= 6 months
At least 18 years of age at time of enrollment
Able to access online exercise program at home
Ability to tolerate the prescribed resistance exercise program
English-speaking
Able to understand and sign the study specific informed consent form (ICF)

Patient Q&A Section

How many people get prediabetic state a year in the United States?

"We calculated that every 3 years, over 1 million US people develop prediabetes. Many are prediabetic for many years without medical detection. A substantial proportion of persons with prediabetes later develop type 2 diabetes." - Anonymous Online Contributor

Unverified Answer

What causes prediabetic state?

"It is still controversial whether the prediabetic state increases the risk of diabetes. Some studies show that prediabetic is associated with an increased risk of diabetes. Other observational studies have shown a protective effect of prediabetic status on future diabetes. However, meta-analyses of observational studies did not show an association between prediabetic states and the risk of diabetes." - Anonymous Online Contributor

Unverified Answer

What are the signs of prediabetic state?

"In summary, prediabetic subjects lack a healthy lifestyle. They have an increased body mass index (BMI), are more likely to display a sedentary (rather than an active) lifestyle, show signs of impaired sleep hygiene (hypersomnia and insomnia), have higher blood pressure, and have a higher incidence of hyperglycaemia, dyslipidaemia and hyperglycaemia. There is also a correlation between BMI and hyperglycaemia (P < 0.01)." - Anonymous Online Contributor

Unverified Answer

Can prediabetic state be cured?

"Results from a recent clinical trial of the experiment have demonstrated the curative efficacy of the combination of GGT elevation and an intensive intervention to prevent HPLD." - Anonymous Online Contributor

Unverified Answer

What is prediabetic state?

"Diabetes was present in only one out of three subjects with prediabetes. Type 2 diabetes was more common in participants with prediabetes than in controls. Subjects with prediabetes showed significantly decreased fasting or post-challenge plasma glucose concentrations, relative to controls. The data suggest that prediabetic subjects may have a lower risk of developing overt diabetes than normal subjects." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prediabetic state?

"While the benefits of lifestyle changes to prevent prediabetics and their families are well acknowledged, more data are needed to help direct specific treatment strategies and interventions in prediabetics and their families. Obesity remains a health problem and lifestyle modification alone is insufficient to prevent, reduce, or treat obesity. There are currently limited data on the use of medication in prediabetics because of the limited number of people available for treatment of prediabetes at their clinics." - Anonymous Online Contributor

Unverified Answer

How does exercise intervention work?

"Results from a recent paper strongly support exercise training as an effective therapeutic modality to help improve glucose control in patients with T2DM without substantial improvement in aerobic fitness. To obtain additional insights, further research of this type targeting the genetic predisposition of the patient is also essential." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of prediabetic state?

"Prediabetic state is a multifactorial condition in which a complex interplay of genetic, epigenetic, nutritional, and environmental factors govern susceptibility to and progression from prediabetes to metabolic disease. The primary causes of prediabetes differ somewhat with gender. Dietary factors, such as adherence to a Mediterranean diet, are associated with a decreased risk of developing prediabetes among women, but not among men." - Anonymous Online Contributor

Unverified Answer

Has exercise intervention proven to be more effective than a placebo?

"While more research into the effects of exercise needs to be conducted, research shows that exercise training can help to lower blood glucose, and that the reduction in glucose and the improvement in insulin sensitivity can help individuals to be in a healthier state. A healthy individual can help by participating in an exercise program, and in these cases, exercise training (including endurance training and strength training) have shown to be more effective to take advantage of the benefits of exercise than a passive movement (such as yoga), regardless of the duration of the program." - Anonymous Online Contributor

Unverified Answer

Does exercise intervention improve quality of life for those with prediabetic state?

"Results from a recent clinical trial of this study indicate that patients in moderate-severe pain, on a prediabetic state, who participate in a home-based PA program have improved QoL as compared to patients who continue on their usual prediabetic state. Results from a recent clinical trial is the first to evaluate the change in QoL in patients who are in a prediabetic state, exercising and experiencing moderate-severe pain, and who have been receiving ongoing medical treatment for weight loss. Exercise has been found to improve QoL by improving physical function." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of exercise intervention?

"A total of 35.5% of exercise intervention study participants reported one or more side effects from exercise intervention. Some side effects of exercise intervention were minor, and were not significantly different from controls in terms of severity and duration." - Anonymous Online Contributor

Unverified Answer

Does prediabetic state run in families?

"Genetic factors may explain only a small part of the variation in prediabetes incidence in the Framingham Offspring Study cohort. The familial nature of this condition appears to not run in families." - 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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