Inflammation's Impact on Heart Disease and Diabetes

NCT06752018 | Recruiting

• 1 other identifier: 1-10-72-91-24
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the inflammatory response associated with cardiometabolic diseases, and whether these can be reduced by ex vivo treatment with therapeutic agents. Briefly, the study involves two populations: healthy volunteers and severely obese patients undergoing weight-loss surgery. The main questions the study seeks to address are:

• Undergo initial testing to evaluate their baseline response.
• Provide samples during surgery for further analysis.
• Participate in follow-up assessments to track changes over time.

Conditions

Inflammation; Obesity and Type 2 Diabetes; Obesity; Metabolic Syndrome; Anti-Inflammatory Agents

Keywords

Disease; Overweight; overnutrition; body weight; Insulin resistance; Inflammation; Anti-Inflammatory Agents

Outcome Measures

Primary Outcomes (2)

• Whole blood ROS prooduction

  The primary endpoint of the study is the therapeutic agent-induced reduction in reactive oxygen species (ROS) production in whole blood, following stimulation with N-Formylmethionyl-leucyl-phenylalanine (fMLP), escherichia coli (E. coli), and phorbol myristate acetate (PMA).

  At baseline and 1 year post surgery

• Whole blood ROS production

  The primary endpoint of the study is the therapeutic agent-induced reduction in ROS production in whole blood, following stimulation with fMPL, E. coli, or PMA

  At the time of enrollment

Study Arms (2)

Obese gastric bypass patients

Procedure: Gastric bypass

Lean healthy controls

Interventions

Gastric bypass PROCEDURE

Roux-en-Y gastric bypass or sleeve gastrectomy

Obese gastric bypass patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy controls and obese patients, scheduled to undergo bariatric surgery without a pre-surgical diet

You may qualify if:

• Individuals willing and able to give appropriate oral and written informed consent
• Men and women over 18 years of age.
• Correct body mass index (BMI) (Lean controls: 18.5-24.9 kg/m2. Obese gastric bypass patients: 35-50 kg/m2)

You may not qualify if:

• The individual does not follow instructions given in the research study.
• Pregnancy.
• Significant gastrointestinal problems.
• Use of tobacco.
• The individual consumed alcohol within two days prior to the study visit
• Active cancer within 5 years.
• Use of dietary supplements that impact the inflammatory resolution process (e.g., fish oils), and the person is not willing to discontinue the use of the supplements 1 week prior to the visits.
• Underlying cardiometabolic disease, or medication related to such disease (e.g., blood pressure medication, insulin to treat diabetes, etc.).
• Underlying inflammatory disease, or medication related to such disease.
• The individual states that they have increased bleeding tendency or are using anti-coagulant (blood-thinning) medication.
• For obese patients only: The individual has lost more than 8% of his/her body weight since their clinical referral for surgery or has lost more than 3% of his/her body weight in the 4 months leading up to surgery.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Omental adipose tissue * Subcutaneous adipose tissue * Whole blood * Plasma * Serum * Feces * Saliva * Liver * Intestine

MeSH Terms

Conditions

Inflammation; Obesity; Diabetes Mellitus, Type 2; Metabolic Syndrome; Disease; Overweight; Overnutrition; Body Weight; Insulin Resistance

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Emma Börgeson, Dr., PhD, MSc

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Börgeson, MSc

CONTACT

+45 9352 2984; emma.borgeson@biomed.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: January 30, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 3, 2025

Record last verified: 2024-12

Locations

DK (1)