The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer

Prediabetes Clinical Trial

Official title:

The Effect of Exercise and Nicotinamide Riboside on Muscle Health and Insulin Resistance in Adult Survivors of Childhood Cancer With Prediabetes: A Pilot Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05023993
• Other study ID #: 20676
• Secondary ID: NCI-2021-0280720
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies the effect of exercise and nicotinamide riboside on muscle health and insulin resistance in adult survivors of childhood cancer with prediabetes (elevated blood sugar level that is not high enough to be considered diabetes). Nicotinamide riboside is a dietary supplement which is similar to vitamin B3. Information collected in this study may help the future development of regimens to improve metabolic outcomes such as muscle health and insulin resistance (when the body is not normally responding to insulin) in childhood cancer survivors.

Description:

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of conducting a home exercise and nutrition intervention in childhood cancer survivors (CCS) with a history of prediabetes.

EXPLORATORY OBJECTIVES:

I. Describe the association between patient demographics and treatment exposures and subsequent hyperglycemia and skeletal muscle health in childhood cancer survivors.

II. Describe the effect of exercise with or without nicotinamide riboside (NR) on hyperglycemia and skeletal muscle health in CCS with a history of prediabetes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.

ARM II: Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside orally (PO) daily for 6 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Taking a nicotinamide adenine dinucleotide (NAD)+ precursor in the two weeks prior to enrollment

• Currently taking medication for hyperglycemia or diabetes

• Females who are pregnant or planning to become pregnant

• Currently recovering from an injury

• Contraindication to magnetic resonance imaging (MRI)

• Pacemaker

Related Conditions & MeSH terms

• Glucose Intolerance
• Hematopoietic and Lymphoid Cell Neoplasm
• Insulin Resistance
• Malignant Solid Neoplasm
• Neoplasms
• Prediabetes
• Prediabetic State

Intervention

Other:
• Exercise Intervention
Complete home exercise

Dietary Supplement:
• Nicotinamide Riboside
Given PO

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS)	The current protocol will be considered feasible if: >= 50% of eligible patients that are approached for participation enroll onto the study,; >= 70% of enrolled participants successfully complete all study assessments (i.e. physical function tests, blood draw, imaging, and questionnaires at baseline and 6 weeks, and; Enrolled participants demonstrate >= 70% compliance with prescribed exercise and nicotinamide riboside.; Feasibility measures 2 and 3 will be assessed for the entire group of 20 subjects as a whole.	Up to 6 weeks