A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis

NCT06350149 | Recruiting

• 2 other identifiers: STUDY000046371R21DK128731-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Glycemic Index; Cystic Fibrosis Related Diabetes

Outcome Measures

Primary Outcomes (7)

• Recruitment Rate

  Recruitment rate of participants. Goal is to recruit 3 participants per month.

  2 years

• Refusal Rate

  Refusal rates for participation. 20%of screened participants will refuse to participate

  2 years

• Investigator Fidelity

  Capacity of the research team to manage the intervention. Goal is \>85%.

  2 years

• Participant Fidelity

  Feasibility of data collection, including primary and secondary outcome measures. Goal is \>85%

  2 years

• Acceptability

  Acceptability and burden of intervention on participants. Likert scale response of \>3(out of 5) on post study evaluation that study is not burdensome and acceptable

  2 years

• Retention Rates

  Retention rates as the participants complete the intervention. Goal is \>80%

  2 years

• Recruitment

  Length of time it takes to recruit enough participants into the study. Goal is to recruit all patients by the end of second quater of the second year.

  2 years

Secondary Outcomes (15)

• Change in plasma Cysteine (Cys)

  Baseline, 2 hours

• Change in plasma Cystine (CySS)

  Baseline, 2 hours

• Change in plasma Glutathione (GSH)

  Baseline, 2 hours

• Change in plasma Glutathione Disulfide (GSSG)

  Baseline, 2 hours

• Change in redox potentials (EhCys/ CySS and EhGSH/GSSG)

  Baseline, 2 hours

Study Arms (4)

SSB+ HI- GI

EXPERIMENTAL

All standardized mixed meal challenges will be similar in calories (kcal) and percent of calories from carbohydrates (45%), protein (15%), and fat (40%). Each meal will provide 1/3rd of the subject's estimated kcal needs per current CF nutrition guidelines

Other: Sugar Sweetened Beverages (SSB); Other: Hi GI

SSB + LO- GI

EXPERIMENTAL

All standardized mixed meal challenges will be similar in calories (kcal) and percent of calories from carbohydrates (45%), protein (15%), and fat (40%). Each meal will provide 1/3rd of the subject's estimated kcal needs per current CF nutrition guidelines

Other: Sugar Sweetened Beverages (SSB); Other: Lo GI

NSSB+ HI- GI

EXPERIMENTAL

All standardized mixed meal challenges will be similar in calories (kcal) and percent of calories from carbohydrates (45%), protein (15%), and fat (40%). Each meal will provide 1/3rd of the subject's estimated kcal needs per current CF nutrition guidelines

Other: Hi GI

NSSB+ LO- GI

EXPERIMENTAL

All standardized mixed meal challenges will be similar in calories (kcal) and percent of calories from carbohydrates (45%), protein (15%), and fat (40%). Each meal will provide 1/3rd of the subject's estimated kcal needs per current CF nutrition guidelines

Other: Lo GI

Interventions

Sugar Sweetened Beverages (SSB) OTHER

The following are considered SSBs: non-diet soft drinks/sodas, flavored juice drinks, sweetened tea, energy drinks, and electrolyte replacement drinks.

SSB + LO- GI; SSB+ HI- GI

Hi GI OTHER

The Glycemic Index of the high-GI meals will be at least 75

Also known as: Hight Glycemic Index Meal

NSSB+ HI- GI; SSB+ HI- GI

Lo GI OTHER

The Glycemic Index of the low- -GI meals will not be higher than 55.

Also known as: Low Glycemic Index Meal

NSSB+ LO- GI; SSB + LO- GI

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English speaking
• Diagnosis of CF based on the presence of two known CF causing mutations and/or positive sweat test
• Pancreatic insufficiency
• Baseline dietary consumption of \>10% total kcal from added sugars and self-reported consumption of \>/= sugar-sweetened beverages per week

You may not qualify if:

• Current use or anticipated use of medication that is known to raise or lower blood glucose in the past 4 weeks.
• Oral or IV glucocorticoid current or previous use in the past 4 weeks will prohibit enrollment in the study.
• Recent pulmonary exacerbation within 3 weeks of enrollment and/or an acute illness requiring a change in antibiotics will also exclude participants.
• BMI below the 5th percentile or greater than the 95th percentile for age and sex
• FEV1 \<40% or awaiting a lung transplant;
• Prior lung or liver transplant or kidney or liver dysfunction.
• Diagnosis of CF liver disease.
• Uncontrolled exocrine pancreatic insufficiency/malabsorption
• Diagnosis of CFRD
• G-tube feeds (bolus and/or continuous)
• Current enrollment in another intervention study
• Changes in diet to lose or gain weight
• Gluten allergy or intolerance
• Current pregnancy or lactation or plans to become pregnant during study period
• History of drug or alcohol abuse

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Center for Advanced Pediatrics: Emory Healthcare

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Sugar-Sweetened Beverages

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Tanicia Daley, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanicia Daley, MD, MPH

CONTACT

404-785-5437; tanicia.daley@emory.edu

Jocelyn McNeany

CONTACT

jocelyn.villalobos.mcneany@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 5, 2024
• Study Start: March 22, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

US (1)