RECRUITING

A Study of Niacin Regulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Adults who gain most of their excess weight in the abdominal area typically do not respond to things that "turn off" fat cells the same way as lean people. The researchers are trying to understand why fat tissue responds differently in people with different body types.

Official Title

Niacin Regulation of Regional Adipose Tissue Lipolysis

Quick Facts

Study Start:2024-01-01

Study Completion:2027-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06175403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Males and females between 18 and 65 years of age who are able to comprehend instructions, follow study procedures, willing to sign an informed consent form, and consume an isoenergetic diet eating all meals from Mayo CRTU for at least 3 days prior to study. * Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2. * Upper body/visceral obesity (UBO) in women will be defined as those with a waist-hip ratio (WHR) \> 0.85 and/or increased visceral fat by single slice CT scan, usually with \> 120 cm2 of visceral fat by CT scanning or a visceral fat/total fat ratio of \> 0.30, and/or biochemical evidence of metabolic syndrome as defined by ATP III criteria (fasting plasma triglycerides ≥ 150 mg/dL, HDL-cholesterol \< 50 mg/dL for women and \< 40 mg/dL for men, fasting plasma glucose ≥ 100 mg/dL). Upper body obesity in men will be defined as a waist-hip ratio of \> 0.95 and/or increased visceral fat (visceral fat area \> 180 cm2 or a visceral/total fat abdominal ratio by CT of \> 0.40) by single slice CT scan and/or biochemical evidence of metabolic syndrome as defined by ATP III criterial. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia. * Female subjects are eligible if they meet the following criteria: are not pregnant or nursing; all women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test within 48 hours before administering study drug; all women of childbearing potential will use an appropriate contraceptive method, including barrier method, oral contraceptive medication, contraceptive device or abstinence while participating in the study. They will confirm use of one of these methods. * Recent or current research participation in a study that involves an investigational drug. Participants in other clinical trials that involve an investigational drug will not be able to participate in this study until 12 weeks after their participation in the other study is complete or \> than five half-lives of the compound, whichever is longer: if Yes look at consent form and f/u visits: current use of medications that alter fatty acid or adipose metabolism possibly given: if yes, exclude; * Amount of blood drawn during the study (if our study plus this one draw ≥ 450 ml these should be separated by 8 weeks. * Previous labs: HbA1C \< 6.5% for non-diabetic UBO; Fasting glucose \< 126 mg/dl for non-diabetic UBO; Hb ≥ 11.0 for women and ≥ 12 for men; platelets \> 100 000.	* Individuals with a history of a disease process such as: ischemic heart disease; atherosclerotic valvular disease; persistent blood pressure greater than 160/95 despite antihypertensive medication. * Smokers. * Concomitant use of medications that can alter free fatty acid metabolism: high dose fish oil (\>3g per day), (if yes, discontinue for 6 weeks); statins (if yes hold for 4 weeks and receive primary care provider's approval); Niacin; Fibrates; thiazolidinediones; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; any history of use of pioglitazone; atypical antipsychotics. * Allergy to lidocaine. * Allergy to Niaspan documented by immunological testing. * Allergy to indocyanine green.

Inclusion Criteria

Exclusion Criteria

* Males and females between 18 and 65 years of age who are able to comprehend instructions, follow study procedures, willing to sign an informed consent form, and consume an isoenergetic diet eating all meals from Mayo CRTU for at least 3 days prior to study.
* Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2.
* Upper body/visceral obesity (UBO) in women will be defined as those with a waist-hip ratio (WHR) \> 0.85 and/or increased visceral fat by single slice CT scan, usually with \> 120 cm2 of visceral fat by CT scanning or a visceral fat/total fat ratio of \> 0.30, and/or biochemical evidence of metabolic syndrome as defined by ATP III criteria (fasting plasma triglycerides ≥ 150 mg/dL, HDL-cholesterol \< 50 mg/dL for women and \< 40 mg/dL for men, fasting plasma glucose ≥ 100 mg/dL). Upper body obesity in men will be defined as a waist-hip ratio of \> 0.95 and/or increased visceral fat (visceral fat area \> 180 cm2 or a visceral/total fat abdominal ratio by CT of \> 0.40) by single slice CT scan and/or biochemical evidence of metabolic syndrome as defined by ATP III criterial. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia.
* Female subjects are eligible if they meet the following criteria: are not pregnant or nursing; all women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test within 48 hours before administering study drug; all women of childbearing potential will use an appropriate contraceptive method, including barrier method, oral contraceptive medication, contraceptive device or abstinence while participating in the study. They will confirm use of one of these methods.
* Recent or current research participation in a study that involves an investigational drug. Participants in other clinical trials that involve an investigational drug will not be able to participate in this study until 12 weeks after their participation in the other study is complete or \> than five half-lives of the compound, whichever is longer: if Yes look at consent form and f/u visits: current use of medications that alter fatty acid or adipose metabolism possibly given: if yes, exclude;
* Amount of blood drawn during the study (if our study plus this one draw ≥ 450 ml these should be separated by 8 weeks.
* Previous labs: HbA1C \< 6.5% for non-diabetic UBO; Fasting glucose \< 126 mg/dl for non-diabetic UBO; Hb ≥ 11.0 for women and ≥ 12 for men; platelets \> 100 000.

* Individuals with a history of a disease process such as: ischemic heart disease; atherosclerotic valvular disease; persistent blood pressure greater than 160/95 despite antihypertensive medication.
* Smokers.
* Concomitant use of medications that can alter free fatty acid metabolism: high dose fish oil (\>3g per day), (if yes, discontinue for 6 weeks); statins (if yes hold for 4 weeks and receive primary care provider's approval); Niacin; Fibrates; thiazolidinediones; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; any history of use of pioglitazone; atypical antipsychotics.
* Allergy to lidocaine.
* Allergy to Niaspan documented by immunological testing.
* Allergy to indocyanine green.

Contacts and Locations

Study Contact

Pamela Reich

CONTACT

507-255-6062

reich.pamela@mayo.edu

Kelli Lytle, PhD

CONTACT

lytle.Kelli@mayo.edu

Principal Investigator

Michael Jensen, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55904

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Michael Jensen, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01

Study Completion Date2027-05-31

Study Record Updates

Study Start Date2024-01-01

Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

Excessive Weight Gain