Cystic FibrosisNCT06350149
A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis
A study testing Sugar Sweetened Beverages (SSB), Hi GI and Lo GI in people with Cystic Fibrosis, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Sugar Sweetened Beverages (SSB), Hi GI and Lo GI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 18Show fewer
- Use of CFTR modulators is not an exclusion criterion. Rather, for patients recently started on CFTR modulators, we will wait to enroll in the study until on CFTR modulator for at least 2 months.
- 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
- Restrictive dietary patterns (e.g, vegan, ketogenic, intermittent fasting) for more than one month within the last two months prior to screening.
- More than 5% body weight change within 2 months of screening visit or Day 1 of mixed meal tolerance test
Trial locations and contacts
1 site in 1 country.
Jocelyn McNeany contact
United States1 site, 1 recruiting
- Recruiting
Center for Advanced Pediatrics: Emory Healthcare
Atlanta, Georgia, 30329
Tanicia Daley, MD, 404-785-5437, tanicia.daley@emory.edu
Arlene Stecenko, MD, 404-727-1460, astecen@emory.edu
About this study
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.
Read the 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 1.2 to 1.5 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Sugar Sweetened Beverages (SSB), Hi GI, Lo GI
- Keywords
- Cystic Fibrosis, Glycemic Index, Cystic Fibrosis Related Diabetes
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Hi GIOther
Also called Hight Glycemic Index Meal
The Glycemic Index of the high-GI meals will be at least 75
Lo GIOther
Also called Low Glycemic Index Meal
The Glycemic Index of the low- -GI meals will not be higher than 55.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Lo GI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Recruitment rate of participants. Goal is to recruit 3 participants per month.
Measured: 2 years
Refusal Rate
Refusal rates for participation. 20%of screened participants will refuse to participate
Measured: 2 years
Investigator Fidelity
Capacity of the research team to manage the intervention. Goal is >85%.
Measured: 2 years
Participant Fidelity
Feasibility of data collection, including primary and secondary outcome measures. Goal is >85%
Measured: 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
Measured: 2 years
Retention Rates
Retention rates as the participants complete the intervention. Goal is >80%
Measured: 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.
Measured: 2 years
Secondary outcomes (15)
Change in plasma Cysteine (Cys)
Systemic redox balance will be assessed by high performance liquid chromatography measurement of plasma CyS
Measured: Baseline, 2 hours
Change in plasma Cystine (CySS)
Systemic redox balance will be assessed by high performance liquid chromatography measurement of plasma CySS
Measured: Baseline, 2 hours
Change in plasma Glutathione (GSH)
Systemic redox balance will be assessed by high performance liquid chromatography measurement of plasma GSH
Measured: Baseline, 2 hours
Change in plasma Glutathione Disulfide (GSSG)
Systemic redox balance will be assessed by high performance liquid chromatography measurement of plasma GSSG
Measured: Baseline, 2 hours
Change in redox potentials (EhCys/ CySS and EhGSH/GSSG)
Systemic redox balance will be assessed by high performance liquid chromatography measurement of plasma redox potentials (EhCys/CySS and EhGSH/GSSG)
Measured: Baseline, 2 hours
Insulinogenic index
It estimates the efficiency of glucose disposal in the early phase of stimulated insulin secretion.
Measured: Baseline, 30 mins
Whole body insulin sensitivity index (WBISI-Matsuda)
Whole-body insulin sensitivity (WBISI) will be assessed by the method of Matsuda and Defronzo, which combines both hepatic and peripheral tissue insulin sensitivity. HOMA-IR will provide a reflection of hepatic insulin resistance.
Measured: 2 hours
Disposition Index
The disposition index, a measure of beta cell function for a given level of insulin resistance, will be calculated as: (WBISI) × (insulin secretion)
Measured: 2 hours
Change in plasma Eh Cys/CySS
Systemic redox balance will be assessed by high performance liquid chromatography measurement of plasma redox potentials EhCys/CySS
Measured: Baseline, 2 hours
Change in incremental glucose AUC
AUC: area under the curve from baseline to 120 minutes
Measured: Baseline, 120 minutes
Changes in Plasma insulin
Changes in post prandial plasma insulin levels will be measured.
Measured: Baseline, 2 hours
Changes in Plasma C-peptide
Changes in post prandial plasma C-peptide levels will be measured.
Measured: Baseline, 2 hours
Changes in Plasma Glucagon
Changes in post prandial plasma glucagon levels will be measured.
Measured: Baseline, 2 hours
Changes in Plasma Incretins: glucagon-like peptide-1 (GLP-1)
Blood for determination of active glucagon-like peptide-1 (GLP-1) will be collected until the 30-minute timepoint in tubes filled with protease inhibitors. GLP-1 will be measured in duplicate by ELISA . The total and iAUC30 will be determined
Measured: Baseline, 2 hours
Changes in Plasma Incretins: total glucose-dependent insulinotropic polypeptide (GIP)
Blood for determination of GIP will be collected until the 30-minute timepoint in tubes filled with protease inhibitors. GLP-1 will be measured in duplicate by ELISA . The total and iAUC30 will be determined
Measured: Baseline, 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start22 Mar 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanicia Daley, Emory University
- Investigators
- Tanicia Daley, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350149
- Sponsor's protocol ID
- STUDY00004637
- Other IDs
- 1R21DK128731-01A1
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06350149
- Acronym / sponsor ID
- STUDY00004637
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Glycemic Index, Cystic Fibrosis Related Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 1.2 to 1.5 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SSB+ HI- GI | Experimental | Other: Sugar Sweetened Beverages (SSB), Other: Hi GIAll 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 |
| SSB + LO- GI | Experimental | Other: Sugar Sweetened Beverages (SSB), Other: Lo GIAll 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 |
| NSSB+ HI- GI | Experimental | Other: Hi GIAll 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 |
| NSSB+ LO- GI | Experimental | Other: Lo GIAll 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 |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugar Sweetened Beverages (SSB)The following are considered SSBs: non-diet soft drinks/sodas, flavored juice drinks, sweetened tea, energy drinks, and electrolyte replacement drinks. | Other | SSB + LO- GI, SSB+ HI- GI |
| Hi GIAlso: Hight Glycemic Index MealThe Glycemic Index of the high-GI meals will be at least 75 | Other | NSSB+ HI- GI, SSB+ HI- GI |
| Lo GIAlso: Low Glycemic Index MealThe Glycemic Index of the low- -GI meals will not be higher than 55. | Other | NSSB+ LO- GI, SSB + LO- GI |
Primary outcome
Recruitment Rate
Time frame: 2 years
Recruitment rate of participants. Goal is to recruit 3 participants per month.
Refusal Rate
Time frame: 2 years
Refusal rates for participation. 20%of screened participants will refuse to participate
Investigator Fidelity
Time frame: 2 years
Capacity of the research team to manage the intervention. Goal is >85%.
Participant Fidelity
Time frame: 2 years
Feasibility of data collection, including primary and secondary outcome measures. Goal is >85%
Acceptability
Time frame: 2 years
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
Retention Rates
Time frame: 2 years
Retention rates as the participants complete the intervention. Goal is >80%
Recruitment
Time frame: 2 years
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.
15 secondary outcomes
Change in plasma Cysteine (Cys)
Time frame: Baseline, 2 hours
Change in plasma Cystine (CySS)
Time frame: Baseline, 2 hours
Change in plasma Glutathione (GSH)
Time frame: Baseline, 2 hours
Change in plasma Glutathione Disulfide (GSSG)
Time frame: Baseline, 2 hours
Change in redox potentials (EhCys/ CySS and EhGSH/GSSG)
Time frame: Baseline, 2 hours
Insulinogenic index
Time frame: Baseline, 30 mins
Whole body insulin sensitivity index (WBISI-Matsuda)
Time frame: 2 hours
Disposition Index
Time frame: 2 hours
Change in plasma Eh Cys/CySS
Time frame: Baseline, 2 hours
Change in incremental glucose AUC
Time frame: Baseline, 120 minutes
Changes in Plasma insulin
Time frame: Baseline, 2 hours
Changes in Plasma C-peptide
Time frame: Baseline, 2 hours
Changes in Plasma Glucagon
Time frame: Baseline, 2 hours
Changes in Plasma Incretins: glucagon-like peptide-1 (GLP-1)
Time frame: Baseline, 2 hours
Changes in Plasma Incretins: total glucose-dependent insulinotropic polypeptide (GIP)
Time frame: Baseline, 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
Related trials for Cystic Fibrosis
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
Not yet recruitingObservational study
Type 2 Inflammation in Adults With Cystic Fibrosis
Cystic Fibrosis (CF), Type 2 Inflammatory Disorders
Active, not recruitingObservational study
Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care
Cystic Fibrosis (CF), Non Cystic Fibrosis Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jocelyn McNeany contact
Tanicia Daley, MD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar Sweetened Beverages (SSB), Hi GI and Lo GI in people with Cystic Fibrosis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tanicia Daley, MD, MPH (404-785-5437, tanicia.daley@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.