Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-22 @ 10:36 PM
Study NCT ID:
NCT03379792
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2017-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
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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.'}, {'pmid': '25413942', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20820753', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19636033', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '16776747', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15207844', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8243815', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8586779', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '6147290', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37576973', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35460915', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.tri-md.org', 'label': 'Translational Research Institute for Metabolism and Diabetes'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females, 19 to 30 years of age, inclusive.\n2. Type 1 Diabetes Cohort:\n\n 1. Diagnosis of type 1 diabetes for greater than 1 year at screening.\n 2. Hemoglobin A1c 6.5-13% or\n\n Control Cohort Without Diabetes:\n\n a. Healthy individuals without diabetes matched to T1D cohort by BMI and gender\n3. Able to provide informed consent.\n4. BMI 18-39.9 kg/m\\^2\n\nExclusion Criteria:\n\n1. Type 2 diabetes\n2. History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, clinically significant abnormalities on EKG, presence of cardiac pacemaker, implanted cardiac defibrillator)\n3. Liver disease (AST or ALT \\>2.5 times the upper limit of normal), history of hepatitis\n4. Kidney disease (creatinine \\>1.6 mg/dl or estimated glomerular filtration rate (GFR)\\<60 ml/min)\n5. Dyslipidemia, including triglycerides \\>800 mg/dl, LDL \\>200 mg/dl\n6. Anemia (hemoglobin \\<12 g/dl in men, \\<11 g/dl in women)\n7. Thyroid dysfunction (suppressed thyroid-stimulating hormone (TSH), elevated TSH \\<10 µIU/ml if symptomatic or elevated TSH \\>10 µIU/ml if asymptomatic)\n8. Uncontrolled hypertension (BP \\>160 mmHg systolic or \\> 100mmHg diastolic)\n9. History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).\n10. Initiation or change in hormone replacement therapy within the past 3 months (including, but not limited to thyroid hormone, birth control or estrogen replacement therapy)\n11. History of organ transplant\n12. History of HIV, active Hepatitis B or C, or Tuberculosis\n13. Pregnancy, lactation or 6 months postpartum from screening visit\n14. History of major depression\n15. Psychiatric disease prohibiting adherence to study protocol\n16. History of eating disorders\n17. Cushing's disease or syndrome\n18. History of bariatric surgery\n19. Tobacco use within the past 3 months\n20. History of drug or alcohol abuse (≥3 drinks per day) within the last 5 years\n21. Use of oral or injectable anti-hyperglycemic agents (except insulin)\n22. Current use of beta-adrenergic blocking agents\n23. Use of antibiotics within the past 3 months\n24. Weight \\>450 lbs (This is DEXA table weight limit)\n25. Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at screening\n26. Unable to participate in MRI or magnetic resonance spectroscopy (MRS) assessment based on Investigator's judgment at screening\n27. Participants with strict dietary concerns (e.g. vegetarian or kosher diet, multiple food allergies, or allergies to food we will provide them during the study)\n28. Gastrointestinal disorders including: inflammatory bowel disease or malabsorption, swallowing disorders, suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastrointestinal surgery, Crohn's disease or diverticulitis.\n29. Presence of any condition that, in the opinion of the investigator, compromises participant safety or data integrity or the participant's ability to complete study visits"}, 'identificationModule': {'nctId': 'NCT03379792', 'acronym': 'ACME', 'briefTitle': 'The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth Translational Research Institute'}, 'officialTitle': 'The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'TRIMDFH 1144866'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 1 Diabetes: BMI Classified as Lean', 'description': 'Participants with type 1 diabetes with a BMI between 18.0-24.9 kg/m\\^2.'}, {'label': 'Type 1 Diabetes: BMI Classified as Overweight', 'description': 'Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m\\^2.'}, {'label': 'Type 1 Diabetes: BMI Classified as Obese', 'description': 'Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m\\^2.'}, {'label': 'Control: BMI Classified as Lean', 'description': 'Control participants without diabetes with a BMI between 18.0-24.9 kg/m\\^2.'}, {'label': 'Control: BMI Classified as Overweight', 'description': 'Control participants without diabetes with a BMI between 25.0-29.9 kg/m\\^2.'}, {'label': 'Control: BMI Classified as Obese', 'description': 'Control participants without diabetes with a BMI between 30.0-39.9 kg/m\\^2.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Translational Research Institute for Metabolism and Diabetes', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Richard Pratley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Translational Research Institute for Metabolism and Diabetes'}, {'name': 'Elizabeth Mayer-Davis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Chapel Hill'}, {'name': 'David M Maahs, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth Translational Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}