Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to

1. Compare effects of two isocaloric meals (processed meat hamburger vs. vegetarian sandwich) in response to the postprandial period by using functional brain imaging of reward circuitry implicated in food motivation and energy balance in patients with type 2 diabetes (T2D), obese subjects and healthy controls.

2. Characterize some of the pathophysiological mechanisms of action of different meals in obese and T2D subjects vs. in healthy controls (serum concentrations of glucose, FFA, IRI, C-peptide, gastrointestinal hormones, oxidative stress markers)


Clinical Trial Description

The mesolimbic dopaminergic system of the brain, which converges on the nucleus accumbens (part of the striatum), plays a central role in reward and craving, and this system appears to mediate hedonic food responses. In rodent studies, extracellular concentrations of dopamine and its metabolites in the nucleus accumbens increased more after the consumption of highly palatable food than standard rodent feed pellets. Furthermore, microinjections of opiate into the nucleus accumbens increased food intake and the reward value of food. Clinical studies that used functional brain imaging have reported greater activation in the nucleus accumbens or other regions of the striatum in obese than lean individuals after they viewed or consumed palatable, high-calorie food. Of particular interest, striatal dopamine D2 receptor availability was significantly lower in obese individuals than in nonobese matched controls, which raised the possibility that overeating may compensate for low dopaminergic activity. The recurrent activation of the striatum may down-regulate dopamine availability and further heighten the drive to overeat. However, the information on the exact effect of different foods and nutrients on the mesolimbic dopaminergic system is missing.

Preliminary findings that lead to the project

A positive association between high consumption of total and red meat, especially processed meat, and incidence of T2D has been demonstrated. Previous studies support the concept that increased oxidative stress may play an important role in T2D manifestation. Dietary fat quality has been proposed to be a critical factor. Several studies have suggested that a high intake of saturated fatty acids naturally present in meat contributes to the risk of glucose intolerance. In an intervention study, humans suffering from metabolic syndrome who were consuming a diet rich in saturated fats displayed higher oxidative stress markers postprandially. It is not clear if saturated fatty acids per se or via increased oxidative stress markers may activate the mesolimbic dopaminergic system.

In contrast, some intervention trials (including ours) demonstrated a greater improvement in insulin sensitivity, glycemic control and a reduction in oxidative stress markers in T2D patients consuming a vegetarian diet compared to a conventional diabetic diet. The effect of a vegetarian diet on the mesolimbic dopaminergic system has not been studied yet.

Aims and priorities of the project

The purpose of this study is to

1. Compare effects of two isocaloric meals (processed meat hamburger vs. vegetarian sandwich) in response to the postprandial period by using functional brain imaging of reward circuitry implicated in food motivation and energy balance in patients with type 2 diabetes (T2D), obese subjects and healthy controls.

2. Characterize some of the pathophysiological mechanisms of action of different meals in obese and T2D subjects vs. in healthy controls (serum concentrations of glucose, FFA, IRI, C-peptide, gastrointestinal hormones, oxidative stress markers)

Hypothesis

1. Obese and T2D subjects relative to lean healthy controls will show greater activation in the gustatory cortex and in somatosensory regions in response to the intake of processed meat hamburger (vs. a vegetarian sandwich). However, they will also show decreased activation in the caudate nucleus in response to consumption of processed meat hamburger (vs. a vegetarian sandwich).

2. Changes in serum concentrations of glucose, FFA, IRI, C-peptide, gastrointestinal hormones and oxidative stress markers will be involved in gut-brain axis signaling. The investigators hypothesise to find an association between postprandial changes in serum concentrations of FFA and postprandial changes in activation in the gustatory cortex and in somatosensory regions of the brain.

The actual need for this study The pandemic of obesity and diabetes especially in western countries calls for high-quality research and relevant action. A better understanding of the pathophysiological mechanisms of the stimulation of brain regions involved in reward and craving in response to processed meat, one of the most significant present risk factors for obesity and type 2 diabetes, is needed in order to develop more effective preventive and therapeutic strategies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02474147
Study type Interventional
Source Institute for Clinical and Experimental Medicine
Contact
Status Completed
Phase N/A
Start date August 2015
Completion date December 2017

See also
  Status Clinical Trial Phase
Completed NCT05219994 - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum N/A
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Completed NCT02284893 - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone Phase 3
Completed NCT04274660 - Evaluation of Diabetes and WELLbeing Programme N/A
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Active, not recruiting NCT05566847 - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed NCT04965506 - A Study of IBI362 in Chinese Patients With Type 2 Diabetes Phase 2
Recruiting NCT06115265 - Ketogenic Diet and Diabetes Demonstration Project N/A
Active, not recruiting NCT03982381 - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes Phase 4
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Completed NCT04023539 - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed NCT03960424 - Diabetes Management Program for Hispanic/Latino N/A
Completed NCT04097600 - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets Phase 1
Completed NCT05378282 - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Active, not recruiting NCT06010004 - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Phase 3
Completed NCT03653091 - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes N/A