Determination of Insulin-stimulated Hepatic Glucose Uptake by PET-CT

Status Recruiting

Clinical Trial Summary

In the absence of excessive alcohol consumption, increased levels of fat in the liver (>5%) are diagnosed as non-alcoholic fatty liver (NAFL). It has been shown that NAFL is strongly associated with impairments in metabolic health such as hepatic and whole-body insulin resistance. Insulin resistance is seen as the earliest hallmark in the development of type 2 diabetes. Insulin has two main effects on the liver: suppressing endogenous glucose production (EGP) and increasing glucose uptake. While the former has been extensively studied and is known to be impaired in NAFL, no studies have yet examined whether insulin-stimulated hepatic glucose uptake is affected by NAFL. Recent methodological developments allow us to visualize and quantify glucose uptake in any given tissue using dynamic Positron Emission Tomography (PET) with 18Fluorinated glucose tracer (FDG) during insulin stimulation. In the present study, we will in a first instance optimize the insulin-stimulated whole-body PET protocol and apply the dose as reported in the literature 4 megabequerels per kg of body weight (MBq/kg) (±8 mSv) in the first three subjects. It will then be evaluated whether the dose can be decreased in the remaining measurements. Another twelve individuals will then undergo the optimized dynamic PET protocol to assess insulin-stimulated hepatic glucose together with whole-body glucose uptake measures. Liver fat content and composition will be assessed by proton magnetic resonance spectroscopy (1H-MRS). Fasted De Novo Lipogenesis (DNL) will also be measured by deuterated water. Additionally, a two-step clamp will be performed to measure whole-body insulin sensitivity and insulin-stimulated suppression of EGP. The identification of the contributing factors to insulin resistance during the development of NAFL is crucial in order to develop more effective strategies for the prevention and treatment of metabolic disorders.

Clinical Trial Description

Objective: To determine the association between insulin-stimulated hepatic glucose uptake measured by dynamic PET and liver fat content in overweight/obese subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04938544
Study type	Observational
Source	Maastricht University Medical Center
Contact	Jeremy B Sagarminaga, MSc
Phone	0638145779
Email	jeremy.basset.s@gmail.com
Status	Recruiting
Phase
Start date	August 1, 2021
Completion date	May 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03142633` - MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Recruiting	`NCT04984226` - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD	Phase 2
Recruiting	`NCT05354245` - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)	N/A
Completed	`NCT03383822` - Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance	Phase 1/Phase 2
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Suspended	`NCT03652987` - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT04203238` - Potato Research for Enhancing Metabolic Outcomes	N/A
Recruiting	`NCT03658564` - Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance	N/A
Completed	`NCT04183257` - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics	Phase 4
Completed	`NCT04117802` - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome	N/A
Completed	`NCT03627104` - Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity	N/A
Completed	`NCT05124847` - TREating Pediatric Obesity	N/A
Active, not recruiting	`NCT03288025` - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)	N/A
Completed	`NCT03809182` - Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.	Phase 4
Completed	`NCT01809288` - Identifying Risk for Diabetes and Heart Disease in Women
Completed	`NCT04642482` - Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity	Phase 4
Terminated	`NCT03278236` - Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?	N/A
Not yet recruiting	`NCT06159543` - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes	N/A
Withdrawn	`NCT04741204` - Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer	Phase 4
Not yet recruiting	`NCT05540249` - Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Determination of Insulin-stimulated Hepatic Glucose Uptake by PET-CT Measurements — ISGU

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms