Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350149
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-28
Brief Title:
A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes CFRD development The main questions it aims to answer are
Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible
What are the preliminary changes in postprandial hyperglycemia islet cell function and incretin response to a high or low Glycemic Index mixed meal tolerance test MMTT with and without Sugar-Sweetened Beverages SSB in adolescents and young adults with CF
Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge
Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible
What are the preliminary changes in postprandial hyperglycemia islet cell function and incretin response to a high or low Glycemic Index mixed meal tolerance test MMTT with and without Sugar-Sweetened Beverages SSB in adolescents and young adults with CF
Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge
Detailed Description:
Cystic fibrosis-related diabetes CFRD is one of the most common co-morbidities seen in CF and significantly increases morbidity and mortality The prevalence of CFRD increases with age with approximately 20 of adolescents and 50 of adults in the 3rd and 4th decade of life carrying the diagnosis Although a diagnosis of CFRD is uncommon in children less than 10 years of age research studies show that abnormal glucose tolerance is found in about 40 of CF toddlers and school-age children Mechanisms leading to the development of CFRD are incompletely understood For several years the predominant theory of pancreatic endocrine dysfunction was based on the theory of collateral damage which results in impairment of β-cell function due to loss of islet cells In addition to experiencing reduced beta cell mass individuals with CF have a diminished incretin effect that contributes to impaired insulin secretion Postprandial hyperglycemia is not uncommon for individuals with CF irrespective of their glucose tolerance and during an OGTT failure to suppress glucagon results in hyperglycemia Unfortunately mechanisms involved in dysregulated glucagon release and its contribution to hyperglycemia in CF are poorly understood
The CF diet is typically high in energy-dense nutrient-poor foods Individuals with CF require high-energy high-fat diets to maintain their hypermetabolic state and offset malabsorption with current CF dietary guidelines recommending an energy intake of 12 to 15 times that of the general population To date there is a paucity of studies that rigorously investigate the metabolic sequelae that high GI foods and SSB have on the metabolic profile of individuals with CF The study team proposes that a diet high is SSBs and high GI foods induces more oxidative stress due to postprandial hyperglycemia impairs insulin secretion and exacerbates glucose abnormalities in CF
The CF diet is typically high in energy-dense nutrient-poor foods Individuals with CF require high-energy high-fat diets to maintain their hypermetabolic state and offset malabsorption with current CF dietary guidelines recommending an energy intake of 12 to 15 times that of the general population To date there is a paucity of studies that rigorously investigate the metabolic sequelae that high GI foods and SSB have on the metabolic profile of individuals with CF The study team proposes that a diet high is SSBs and high GI foods induces more oxidative stress due to postprandial hyperglycemia impairs insulin secretion and exacerbates glucose abnormalities in CF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21DK128731-01A1 | NIH | None | httpsreporternihgovquickSearch1R21DK128731-01A1 |