Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's National Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
This study will investigate whether low-calorie sweeteners (LCS) are helpful or harmful for preventing diabetes complications among children with Type 1 Diabetes (T1D).
Eligible participants will be scheduled for a baseline visit. During the week prior, they will be instructed to continue usual dietary habits and complete an online photo-assisted food record, with parental assistance. At the baseline visit, height and weight will be measured, a spot urine sample will be collected, and a blood draw will be performed. Participants will have their CGM data for the past two weeks downloaded. In a subset of participants, an abdominal MRI will also be performed.
Subjects will then be randomized to either: 1) low-calorie sweetener (LCS) restriction or 2) continuation of usual LCS intake (control). All participants (both groups) and their parent will undergo a brief, 20-minute orientation where the PI and study dietitian will provide an introduction to the study, instructions on completing food records, education on CGM. Those in the intervention group will be given sample replacement beverages and a brochure on avoiding LCS to take home which will include a list of specific foods and beverages containing LCS to avoid during the study. Participants in the control group will be counseled on healthy eating as those in the intervention group (in accordance with standard dietary guidance for T1D management), with the exception of information and resources for avoiding LCS.
In both groups, text messages will be sent to parents 3X/week with reminders that their child should avoid LCS or continue usual intake, per randomization. Adherence will be monitored through collection of spot-urine samples for measurement of sucralose and ace-K concentrations. daily text message beverage logs completed by the parent, and photo-assisted food records with parent assistance in Weeks 0, 1, 6, and 12. During Week 6, participants and their parent will attend a mid-intervention telemedicine booster visit, during which the PI and/or study RA will reinforce the intervention and remind participants to mail back a spot urine sample using materials provided by the study team at baseline. Participants will be reminded of the study instructions, including the importance of inserting the DEXCOM G6 sensor (provided by study team) at the beginning of Week 11.
At the end of Week 12, participants and their parent will return for follow-up. Participants will have their CGM data downloaded using DEXCOM Clarity™ software. Height and weight will be measured and a second blood draw performed. Those who had an MRI at the baseline visit (n=30) will undergo a second abdominal MRI. Those randomized to the intervention will be purposefully sampled and asked to complete a ~20 minute qualitative interview and ~5 minute satisfaction survey, together with their parent, about their study experience and the challenges of LCSB restriction.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-calorie sweetener restriction | Experimental | Participants will be instructed to avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks. |
|
| Usual consumption/control | No Intervention | Participants will continue low-calorie sweetener consumption, as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-calorie sweetener restriction | Behavioral | Participants will avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners for 12 weeks and will instead consume unsweetened alternatives, such as still or sparkling water |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Variability | Change in Time in Range (TIR) | Baseline vs Weeks 11-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Visceral Adiposity | Change in visceral fat area will be assessed using DXA. Due to COVID-19, very few participants were able to have visceral fat measured pre and post intervention. | Baseline vs. Week 12 |
| Change in Inflammatory Cytokines (TNF-alpha) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33974993 | Derived | Sylvetsky AC, Moore HR, Kaidbey JH, Halberg SE, Cogen FR, DiPietro L, Elmi A, Goran MI, Streisand R. Rationale and design of DRINK-T1D: A randomized clinical trial of effects of low-calorie sweetener restriction in children with type 1 diabetes. Contemp Clin Trials. 2021 Jul;106:106431. doi: 10.1016/j.cct.2021.106431. Epub 2021 May 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The reason that the number started does not equal the total enrollment is because there was a run-in period, prior to randomization, where 3 children (6 total participants including the child's parent) were lost to follow-up.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Low-calorie Sweetener Restriction: Children | Participants will be instructed to avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks. Low-calorie sweetener restriction: Participants will avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners for 12 weeks and will instead consume unsweetened alternatives, such as still or sparkling water |
| FG001 | Usual Consumption/Control: Children | Participants will continue low-calorie sweetener consumption, as usual. |
| FG002 | Low-calorie Sweetener Restriction: Parents | Participants will be instructed to have their child avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks. |
| FG003 | Usual Consumption/Control: Parents | Participants'children will continue low-calorie sweetener consumption, as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-in Period |
| |||||||||||||
| Randomized to Intervention or Control |
|
Baseline characteristics were not collected for parents.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low-calorie Sweetener Restriction: Children | Participants will be instructed to avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks. Low-calorie sweetener restriction: Participants will avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners for 12 weeks and will instead consume unsweetened alternatives, such as still or sparkling water |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycemic Variability | Change in Time in Range (TIR) | The outcome was measured only among children who completed the study. | Posted | Mean | Standard Deviation | percent | Baseline vs Weeks 11-12 |
|
Adverse event data were collected for each participant during the 14 weeks they were enrolled in the study.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-calorie Sweetener Restriction: Children | Participants will be instructed to avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks. Low-calorie sweetener restriction: Participants will avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners for 12 weeks and will instead consume unsweetened alternatives, such as still or sparkling water |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Sylvetsky | George Washington University | 202-994-5602 | asylvets@gwu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2021 | Aug 20, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We will collect a blood sample to measure TNF-alpha and calculate the change from baseline.
| Baseline vs Week 12 |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Usual Consumption/Control: Children | Participants will continue low-calorie sweetener consumption, as usual. |
| BG002 | Low-calorie Sweetener Restriction: Parents | Participants will be instructed to have their child avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks. |
| BG003 | Usual Consumption/Control: Parents | Participants' children will continue low-calorie sweetener consumption, as usual. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI percentile | Mean | Standard Deviation | percentile |
|
| Time since type 1 diabetes diagnosis | Mean | Standard Deviation | years |
|
Participants will continue low-calorie sweetener consumption, as usual. |
| OG002 | Low-calorie Sweetener Restriction: Parents | Participants will be instructed to have their child avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks. |
| OG003 | Usual Consumption/Control: Parents | Participants' children will continue low-calorie sweetener consumption, as usual. |
|
|
| Secondary | Visceral Adiposity | Change in visceral fat area will be assessed using DXA. Due to COVID-19, very few participants were able to have visceral fat measured pre and post intervention. | Outcomes were assessed for children, not parents | Posted | Mean | Standard Error | % body fat | Baseline vs. Week 12 |
|
|
|
| Secondary | Change in Inflammatory Cytokines (TNF-alpha) | We will collect a blood sample to measure TNF-alpha and calculate the change from baseline. | The outcome was measured among children, not parents. | Posted | Mean | Standard Error | pg/mL | Baseline vs Week 12 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Usual Consumption/Control: Children | Participants will continue low-calorie sweetener consumption, as usual. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Low-calorie Sweetener Restriction: Parents | Participants were instructed to have their child avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Usual Consumption/Control: Parents | Participants' children will continue low-calorie sweetener consumption, as usual. | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |