A Study of Niacin Regulation

Niacin Regulation of Regional Adipose Tissue Lipolysis

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.

Study Overview

• Status: Recruiting
• Conditions: Excessive Weight Gain
• Intervention / Treatment: Drug: Niacin

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Pamela Reich; Phone Number: 507-255-6062; Email: reich.pamela@mayo.edu
• Study Contact Backup: Name: Kelli Lytle, PhD; Email: lytle.Kelli@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55904
      • Recruiting
      • Mayo Clinic
      • Contact: Pamela A. Reich; Phone Number: 507-255-6062; Email: reich.pamela@mayo.edu
      • Contact: Kelli A Lytle, PhD; Email: lytle.kelli@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upper body obesity; Subjects identify with upper body obesity will receive Niacin to lean how fat cells in different regions of the body the response.	Drug: Niacin; Intravenous administration of dose titrated from 10 µg·kg FFM-1·min-1 to 30 µg·kg for approximately 4.5 hours on one occasion
Experimental: Normal weight; Subjects identify with normal body weight will receive Niacin to lean how fat cells in different regions of the body the response.	Drug: Niacin; Intravenous administration of dose titrated from 10 µg·kg FFM-1·min-1 to 30 µg·kg for approximately 4.5 hours on one occasion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma free fatty acid (FFA) concentrations	Measurement of plasma free fatty acid (FFA) concentrations from femoral, upper body subcutaneous adipose tissue expressed as nmol•million adipocytes-1•min-1	Baseline, post treatment (approximately 4 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pHSL/HSL response	Measure of pHSL/HSL level in subcutaneous biopsy samples	approx. 6 hours

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Michael Jensen, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acids, Heterocyclic; Nicotinic Acids; Niacin
• Other Study ID Numbers: 23-003673; 2R01DK040484-35A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No