Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640478
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
A 12-week Clinical Nutrition Trial for Children With New Diagnosis of Stage 3 Type 1 Diabetes T1D
Sponsor:
None
Organization:
None
Study Overview
Official Title:
NUTRI-Beta Study A Pilot Clinical Trial for Children With New Diagnosis of Stage 3 Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUTRI-Beta
Brief Summary:
The purpose of this research study is to investigate the effects of a combination of weekly distribution of healthy foods and intensive nutrition counseling as complementary therapies to the standard insulin therapy in children with new diagnosis of stage 3 type 1 diabetes T1D Feasibility acceptability and fidelity of this intervention will be measured We will also explore the likelihood of prolonging the honeymoon phase in the intervention study group Comparisons will be made between this combined nutrition intervention vs current standard nutrition counseling Both study groups will receive standard of care treatment for type 1 diabetes insulin therapy
The results of this study could inform future research that will ultimately lead to design of a larger clinical trial testing implementation of novel medical nutrition therapies for children newly diagnosed with stage 3 T1D and may lead to prolongation of the honeymoon phase The overall goal is to promote beta cell function survival and to reduce the progression to stage 4 type 1 diabetes
Condition or Disease
Type 1 Diabetes
New Diagnosis of Stage 3 Type 1 Diabetes 45days
InterventionTreatment
- Weekly Free Healthy Foods Intensive Nutrition Counseling for 12 weeks
The results of this study could inform future research that will ultimately lead to design of a larger clinical trial testing implementation of novel medical nutrition therapies for children newly diagnosed with stage 3 T1D and may lead to prolongation of the honeymoon phase The overall goal is to promote beta cell function survival and to reduce the progression to stage 4 type 1 diabetes
Condition or Disease
Type 1 Diabetes
New Diagnosis of Stage 3 Type 1 Diabetes 45days
InterventionTreatment
- Weekly Free Healthy Foods Intensive Nutrition Counseling for 12 weeks
Detailed Description:
The proposed study is a 12-week pilot single-blinded randomized controlled clinical trial in prepubertal children 6-17 years old newly diagnosed with stage 3 type 1 diabetes T1D within 45 days The total duration of the study is six months 24 weeks but the nutrition intervention is only delivered during 12 weeks with a 24-week follow up visit We expect to enroll a total of 12-20 children 6-12 per study group
We will be investigating the potential role of a frequent personalized nutrition counseling intervention hybrid model in addition to weekly distribution of selected healthy foods We expect the diet quality of the youth receiving the intervention will improve during and after the study intervention
There will be two study groups intervention and control group The intervention group will receive a food bag containing specific healthy foods with high anti-inflammatory properties weekly for 12 weeks in addition to seven nutrition counseling sessions The provided foods are a combination of 6 types of foods including a seasonal fruits containing high amounts of vitamin C and vitamin E b legumes c nuts d yogurt e vegetables and f seafood The portions of each food group component of the healthy foods bag will follow the current USDA dietary guidelines according to the age of the study participant 1 By contrast the control group will receive weekly grocery store gift cards of similar monetary value of the healthy food bag in addition to seven nutrition counseling sessions based on the standard MyHealthy plate model
In regards to the nutrition counseling sessions this counseling will be provided as a hybrid model with a combination of 4 in-person nutrition counseling sessions and 3 virtual dietary counseling sessions provided by a registered dietitian In summary
1 Intervention group will receive NUTRI-Beta foods basket nutrition counseling NUTRI-Beta dietary counseling standard insulin treatment either insulin injections or insulin pump per patient preference standard of care insulin therapy and use of a 24-hour continuous glucose monitor and
2 Control group will receive the standard nutrition counseling per the American Dietary Association ADA Guidelines 2ref- 2024 guidelines weekly grocery store gift cards standard of care insulin therapy and use of a 24-hour continuous glucose monitor
The NUTRI-Beta clinical trial study visits will follow the following schedule screening visit V0 baseline enrolment visit V1 nutrition counseling visit 2 week 2 post enrollment nutrition counseling visit 3 V3-virtual week 3 nutrition counseling visit 4 V4-in person week 4 nutrition counseling visit 5 V5-virtual week 6 nutrition counseling visit 6 V6-in person week 8 nutrition counseling visit 7 V7-virtual week 10 visit 8 12 weeks after enrollment- end of nutrition intervention and visit 9 24 weeks after enrollment
We expect that this nutrition intervention NUTRI-Beta will be acceptable to children with new diagnosis of clinical diabetes stage 3 T1D and will improve their diet intake and quality their nutrition status and may increase their likelihood of residual beta-cell function in the treatment group Evaluation of partial remission of T1D will be completed through the determination of the insulin dose-adjusted A1C IDAA1C and residual beta cell function through the measurement of peak C-peptide levels during a 2-hour mixed-meal tolerance test MMTT The treatment group is expected to have higher rates of partial remission of T1D measured by the IDAA1C better diet quality better glycemic metrics and reduced needs of total daily dose of insulin TDD unitkgday
We will be investigating the potential role of a frequent personalized nutrition counseling intervention hybrid model in addition to weekly distribution of selected healthy foods We expect the diet quality of the youth receiving the intervention will improve during and after the study intervention
There will be two study groups intervention and control group The intervention group will receive a food bag containing specific healthy foods with high anti-inflammatory properties weekly for 12 weeks in addition to seven nutrition counseling sessions The provided foods are a combination of 6 types of foods including a seasonal fruits containing high amounts of vitamin C and vitamin E b legumes c nuts d yogurt e vegetables and f seafood The portions of each food group component of the healthy foods bag will follow the current USDA dietary guidelines according to the age of the study participant 1 By contrast the control group will receive weekly grocery store gift cards of similar monetary value of the healthy food bag in addition to seven nutrition counseling sessions based on the standard MyHealthy plate model
In regards to the nutrition counseling sessions this counseling will be provided as a hybrid model with a combination of 4 in-person nutrition counseling sessions and 3 virtual dietary counseling sessions provided by a registered dietitian In summary
1 Intervention group will receive NUTRI-Beta foods basket nutrition counseling NUTRI-Beta dietary counseling standard insulin treatment either insulin injections or insulin pump per patient preference standard of care insulin therapy and use of a 24-hour continuous glucose monitor and
2 Control group will receive the standard nutrition counseling per the American Dietary Association ADA Guidelines 2ref- 2024 guidelines weekly grocery store gift cards standard of care insulin therapy and use of a 24-hour continuous glucose monitor
The NUTRI-Beta clinical trial study visits will follow the following schedule screening visit V0 baseline enrolment visit V1 nutrition counseling visit 2 week 2 post enrollment nutrition counseling visit 3 V3-virtual week 3 nutrition counseling visit 4 V4-in person week 4 nutrition counseling visit 5 V5-virtual week 6 nutrition counseling visit 6 V6-in person week 8 nutrition counseling visit 7 V7-virtual week 10 visit 8 12 weeks after enrollment- end of nutrition intervention and visit 9 24 weeks after enrollment
We expect that this nutrition intervention NUTRI-Beta will be acceptable to children with new diagnosis of clinical diabetes stage 3 T1D and will improve their diet intake and quality their nutrition status and may increase their likelihood of residual beta-cell function in the treatment group Evaluation of partial remission of T1D will be completed through the determination of the insulin dose-adjusted A1C IDAA1C and residual beta cell function through the measurement of peak C-peptide levels during a 2-hour mixed-meal tolerance test MMTT The treatment group is expected to have higher rates of partial remission of T1D measured by the IDAA1C better diet quality better glycemic metrics and reduced needs of total daily dose of insulin TDD unitkgday
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None