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The purpose of this study is to measure the metabolic phenotype of a range of body weights in individuals with and without type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 Diabetes: BMI Classified as Lean | Participants with type 1 diabetes with a BMI between 18.0-24.9 kg/m^2. | ||
| Type 1 Diabetes: BMI Classified as Overweight | Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m^2. | ||
| Type 1 Diabetes: BMI Classified as Obese | Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m^2. | ||
| Control: BMI Classified as Lean | Control participants without diabetes with a BMI between 18.0-24.9 kg/m^2. | ||
| Control: BMI Classified as Overweight | Control participants without diabetes with a BMI between 25.0-29.9 kg/m^2. | ||
| Control: BMI Classified as Obese | Control participants without diabetes with a BMI between 30.0-39.9 kg/m^2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Energy Expenditure | Measured via whole room calorimetry; based on oxygen consumption and carbon dioxide production measured using gas analyzers, as well as 14-hour urinary nitrogen excretion; calculated using established equations. | 24 hours |
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Inclusion Criteria:
Males and females, 19 to 30 years of age, inclusive.
Type 1 Diabetes Cohort:
Control Cohort Without Diabetes:
a. Healthy individuals without diabetes matched to T1D cohort by BMI and gender
Able to provide informed consent.
BMI 18-39.9 kg/m^2
Exclusion Criteria:
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Young adults with type 1 diabetes diagnosed greater than or equal to 1 year prior to screening, or control young adults without diabetes, both within a range of BMI classifications (18-39.9 kg/m^2).
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| Name | Affiliation | Role |
|---|---|---|
| Richard Pratley, MD | Translational Research Institute for Metabolism and Diabetes | Principal Investigator |
| Elizabeth Mayer-Davis, PhD | UNC Chapel Hill | Principal Investigator |
| David M Maahs, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Research Institute for Metabolism and Diabetes | Orlando | Florida | 32804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25998289 | Background | Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078. | |
| 25413942 | Background |
| Label | URL |
|---|---|
| Translational Research Institute for Metabolism and Diabetes | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Type 1 Diabetes: BMI Classified as Lean | Participants with type 1 diabetes who had a BMI between 18.0-24.9 kg/m^2. |
| FG001 | Type 1 Diabetes: BMI Classified as Overweight | Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m^2. |
| FG002 | Type 1 Diabetes: BMI Classified as Obese | Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m^2. |
| FG003 | Control: BMI Classified as Lean | Control participants without diabetes with a BMI between 18.0-24.9 kg/m^2. |
| FG004 | Control: BMI Classified as Overweight | Control participants without diabetes with a BMI between 25.0-29.9 kg/m^2. |
| FG005 | Control: BMI Classified as Obese | Control participants without diabetes with a BMI between 30.0-39.9 kg/m^2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Type 1 Diabetes: BMI Classified as Lean | Participants with type 1 diabetes with a BMI between 18.0-24.9 kg/m^2. |
| BG001 | Type 1 Diabetes: BMI Classified as Overweight | Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m^2. |
| 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 | Energy Expenditure | Measured via whole room calorimetry; based on oxygen consumption and carbon dioxide production measured using gas analyzers, as well as 14-hour urinary nitrogen excretion; calculated using established equations. | Posted | Mean | Standard Deviation | Kilocalories | 24 hours |
|
28-42 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Type 1 Diabetes: BMI Classified as Lean | Participants with type 1 diabetes with a BMI between 18.0-24.9 kg/m^2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard E. Pratley | AdventHealth Translational Research Institute | 407-303-2519 | richard.pratley.md@adventhealth.com |
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| 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 | Oct 23, 2019 | Apr 3, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 23, 2019 | Jun 21, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Chillaron JJ, Benaiges D, Mane L, Pedro-Botet J, Flores Le-Roux JA. Obesity and type 1 diabetes mellitus management. Minerva Endocrinol. 2015 Mar;40(1):53-60. Epub 2014 Nov 21. |
| 20820753 | Background | Maahs DM, Ogden LG, Dabelea D, Snell-Bergeon JK, Daniels SR, Hamman RF, Rewers M. Association of glycaemia with lipids in adults with type 1 diabetes: modification by dyslipidaemia medication. Diabetologia. 2010 Dec;53(12):2518-25. doi: 10.1007/s00125-010-1886-6. Epub 2010 Sep 4. |
| 19636033 | Background | Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group; Nathan DM, Zinman B, Cleary PA, Backlund JY, Genuth S, Miller R, Orchard TJ. Modern-day clinical course of type 1 diabetes mellitus after 30 years' duration: the diabetes control and complications trial/epidemiology of diabetes interventions and complications and Pittsburgh epidemiology of diabetes complications experience (1983-2005). Arch Intern Med. 2009 Jul 27;169(14):1307-16. doi: 10.1001/archinternmed.2009.193. |
| 16776747 | Background | Jacob AN, Salinas K, Adams-Huet B, Raskin P. Potential causes of weight gain in type 1 diabetes mellitus. Diabetes Obes Metab. 2006 Jul;8(4):404-11. doi: 10.1111/j.1463-1326.2005.00515.x. |
| 15207844 | Background | Rigalleau V, Lasseur C, Pecheur S, Chauveau P, Combe C, Perlemoine C, Baillet L, Gin H. Resting energy expenditure in uremic, diabetic, and uremic diabetic subjects. J Diabetes Complications. 2004 Jul-Aug;18(4):237-41. doi: 10.1016/S1056-8727(03)00077-1. |
| 8243815 | Background | Carlson MG, Campbell PJ. Intensive insulin therapy and weight gain in IDDM. Diabetes. 1993 Dec;42(12):1700-7. doi: 10.2337/diab.42.12.1700. |
| 8586779 | Background | Greco AV, Tataranni PA, Mingrone G, De Gaetano A, Manto A, Cotroneo P, Ghirlanda G. Daily energy metabolism in patients with type 1 diabetes mellitus. J Am Coll Nutr. 1995 Jun;14(3):286-91. doi: 10.1080/07315724.1995.10718509. |
| 6147290 | Background | Nair KS, Halliday D, Garrow JS. Increased energy expenditure in poorly controlled Type 1 (insulin-dependent) diabetic patients. Diabetologia. 1984 Jul;27(1):13-6. doi: 10.1007/BF00253494. |
| 37576973 | Derived | Casu A, Nunez Lopez YO, Yu G, Clifford C, Bilal A, Petrilli AM, Cornnell H, Carnero EA, Bhatheja A, Corbin KD, Iliuk A, Maahs DM, Pratley RE. The proteome and phosphoproteome of circulating extracellular vesicle-enriched preparations are associated with characteristic clinical features in type 1 diabetes. Front Endocrinol (Lausanne). 2023 Jul 28;14:1219293. doi: 10.3389/fendo.2023.1219293. eCollection 2023. |
| 35460915 | Derived | Corbin KD, Igudesman D, Addala A, Casu A, Crandell J, Kosorok MR, Maahs DM, Pokaprakarn T, Pratley RE, Souris KJ, Thomas JM, Zaharieva DP, Mayer-Davis EJ; ACT1ON Consortium. Design of the Advancing Care for Type 1 Diabetes and Obesity Network energy metabolism and sequential multiple assignment randomized trial nutrition pilot studies: An integrated approach to develop weight management solutions for individuals with type 1 diabetes. Contemp Clin Trials. 2022 Jun;117:106765. doi: 10.1016/j.cct.2022.106765. Epub 2022 Apr 20. |
| Withdrawal by Subject |
|
| BG002 | Type 1 Diabetes: BMI Classified as Obese | Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m^2. |
| BG003 | Control: BMI Classified as Lean | Control participants without diabetes with a BMI between 18.0-24.9 kg/m^2. |
| BG004 | Control: BMI Classified as Overweight | Control participants without diabetes with a BMI between 25.0-29.9 kg/m^2. |
| BG005 | Control: BMI Classified as Obese | Control participants without diabetes with a BMI between 30.0-39.9 kg/m^2. |
| BG006 | 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 |
|
| Region of Enrollment | Number | participants |
|
| Type 1 Diabetes: BMI Classified as Obese |
Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m^2. |
| OG003 | Control: BMI Classified as Lean | Control participants without diabetes with a BMI between 18.0-24.9 kg/m^2. |
| OG004 | Control: BMI Classified as Overweight | Control participants without diabetes with a BMI between 25.0-29.9 kg/m^2. |
| OG005 | Control: BMI Classified as Obese | Control participants without diabetes with a BMI between 30.0-39.9 kg/m^2. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Type 1 Diabetes: BMI Classified as Overweight | Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m^2. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG002 | Type 1 Diabetes: BMI Classified as Obese | Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m^2. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG003 | Control: BMI Classified as Lean | Control participants without diabetes with a BMI between 18.0-24.9 kg/m^2. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | Control: BMI Classified as Overweight | Control participants without diabetes with a BMI between 25.0-29.9 kg/m^2. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG005 | Control: BMI Classified as Obese | Control participants without diabetes with a BMI between 30.0-39.9 kg/m^2. | 0 | 4 | 0 | 4 | 0 | 4 |
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |