Clinical Trials Logo

Clinical Trial Summary

The aim of this trial was to assess glycemic control and incretin release in subjects affected by type-2 diabetes, a condition in which GLP-1 release is impaired. It is known that nutrition affects a variety of factors in overall quality of life in diabetes and we hypothesized incretin secretion may improve in acute. As little is known regarding oxyntomodulin secretion in relation to diet, we explored this gut-derived hormone behavior as well.

Hence, the administration of two meals was carried out; these were equal in terms of calories but different for macronutrients composition. Appetite rating was assessed as well through a 100-mm horizontal Visual Analogue Scale, either at fasting and for 4 hours once the meal was completed.


Clinical Trial Description

Type-2 diabetes (T2D) is a multifactorial metabolic burden whose metabolic features include alterations in GLP-1 secretion and ultimately hunger/satiety circuit derangement. Manipulating the composition of the diet in order to promote GLP-1 secretion may represent a promising lifestyle strategy for obesity and T2D management.

The objective of this study was to assess the post-prandial profile of appetite- regulating hormones and assessing the post-prandial appetite ratings using a Visual Analogue Scale (VAS), as well as measuring the fasting and postprandial glucose/insulin responses in overweight and/or obese, well controlled patients with T2D.

Twelve T2D patients (M:F = 7:5) aged 63.1±8.5 years were enrolled in a randomized, controlled, crossover trial. Subjects consumed on two different days, at one-week interval, an experimental High Fiber Vegetarian meal (HFV) rich in dietary carbohydrate and fiber in comparison with a standard, Mediterranean-like meal (MED). The two meals were isocaloric. Appetite ratings, glucose/insulin and gastrointestinal hormone responses were assessed either at fasting and every 30' until 210' for GLP-1 and Oxyntomodulin and 240' for glucose and insulin after the ingestion of the meal. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04105608
Study type Interventional
Source Campus Bio-Medico University
Contact
Status Completed
Phase N/A
Start date November 1, 2017
Completion date February 28, 2018

See also
  Status Clinical Trial Phase
Completed NCT02797392 - Feasibility of a Preventive Program Against Lifestyle Related Diseases N/A
Completed NCT01264523 - Nutritional Intervention With Moderately High-protein, Low-glycemic Load Products in Type-2 Diabetes Patients N/A
Completed NCT03624803 - DAPA - Egypt Study
Terminated NCT01787214 - Walnuts and Glucose Variability N/A
Completed NCT01715428 - Liraglutide and Cardio-Metabolic Risk Markers N/A
Completed NCT01884714 - Exploring the Molecular Basis to Healthy Obesity: The Diabetes Risk Assessment Study N/A
Completed NCT00567047 - Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment Phase 1
Completed NCT02191644 - Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes Phase 2
Completed NCT01440660 - Phenotypes of Nonproliferative Diabetic Retinopathy in DM 2 Patients Identified by OCT, CFP, RLA and mfERG (DIAMARKER) N/A
Completed NCT01343589 - Effects of Milk Derived From Mountain-pasture Grazing Cows on Risk Markers of the Metabolic Syndrome Compared to Conventional Danish Milk N/A
Completed NCT00651105 - Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects Phase 3
Completed NCT04330911 - The Effects of Aerobic Exercises on Exercise Capacity in Type-2 Diabetes Mellitus N/A
Completed NCT03269058 - Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes Phase 4
Completed NCT04952948 - Pilates Method on Functional Capacity and Blood Pressure of Elderly Women With Type 2 Diabetes N/A
Completed NCT00478127 - Hepatocyte Growth Factor and Cardiovascular Autonomic Function N/A