Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06175403

A Study of Niacin Regulation

Led by Mayo Clinic · Updated on 2026-04-13

32

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study of Niacin Regulation

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females between 18 and 65 years old who can understand instructions, follow study procedures, and sign consent
  • Agree to eat an isoenergetic diet with all meals from Mayo Clinic for at least 3 days before the study
  • Overweight or obese with a BMI of 29.0 to 40.0 kg/m2
  • Upper body or visceral obesity defined by waist-hip ratio, visceral fat measurements, or metabolic syndrome markers
  • Women not pregnant or nursing, with negative pregnancy tests at screening and within 48 hours before study drug administration
  • Women of childbearing potential must use effective contraception during the study
  • No recent participation in other investigational drug studies within 12 weeks or five half-lives of the drug
  • Total blood drawn in this and other studies does not exceed 450 ml within 8 weeks
  • Laboratory values within specified ranges: HbA1C below 6.5% (non-diabetic), fasting glucose below 126 mg/dL, hemoglobin at least 11.0 for women and 12.0 for men, platelets above 100,000
Not Eligible

You will not qualify if you...

  • History of ischemic heart disease or atherosclerotic valvular disease
  • Persistent high blood pressure over 160/95 mmHg despite medication
  • Current smokers
  • Use of medications affecting fatty acid metabolism such as high-dose fish oil, statins, niacin, fibrates, thiazolidinediones, beta-blockers, corticosteroids, anabolic steroids, pioglitazone, or atypical antipsychotics
  • Allergies to lidocaine, Niaspan (confirmed by testing), or indocyanine green

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic

Rochester, Minnesota, United States, 55904

Actively Recruiting

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Research Team

P

Pamela Reich

CONTACT

K

Kelli Lytle, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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