Type 1 DiabetesACMENCT03379792
The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes
An observational study of Type 1 Diabetes, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2018to 20 Jul 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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).
Who may be able to join
- Males and females, 19 to 30 years of age, inclusive.
- Type 1 Diabetes Cohort:
- Diagnosis of type 1 diabetes for greater than 1 year at screening.
- Hemoglobin A1c 6.5-13% or
- Control Cohort Without Diabetes:
- Healthy individuals without diabetes matched to T1D cohort by BMI and gender
- Able to provide informed consent.
- BMI 18-39.9 kg/m^2
Who cannot join
- Type 2 diabetes
- 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)
- Liver disease (AST or ALT >2.5 times the upper limit of normal), history of hepatitis
- Kidney disease (creatinine >1.6 mg/dl or estimated glomerular filtration rate (GFR)<60 ml/min)
- Dyslipidemia, including triglycerides >800 mg/dl, LDL >200 mg/dl
- Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)
Show all 29Show fewer
- Thyroid dysfunction (suppressed thyroid-stimulating hormone (TSH), elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)
- Uncontrolled hypertension (BP >160 mmHg systolic or > 100mmHg diastolic)
- History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
- 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)
- History of organ transplant
- History of HIV, active Hepatitis B or C, or Tuberculosis
- Pregnancy, lactation or 6 months postpartum from screening visit
- History of major depression
- Psychiatric disease prohibiting adherence to study protocol
- History of eating disorders
- Cushing's disease or syndrome
- History of bariatric surgery
- Tobacco use within the past 3 months
- History of drug or alcohol abuse (≥3 drinks per day) within the last 5 years
- Use of oral or injectable anti-hyperglycemic agents (except insulin)
- Current use of beta-adrenergic blocking agents
- Use of antibiotics within the past 3 months
- Weight >450 lbs (This is DEXA table weight limit)
- Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at screening
- Unable to participate in MRI or magnetic resonance spectroscopy (MRS) assessment based on Investigator's judgment at screening
- 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)
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
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.
- Conditions
- Type 1 Diabetes
- Keywords
- Obesity, Overweight
- Medical subject headings
- Diabetes Mellitus, Type 1, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start8 Mar 2018
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Pratley, MD, Principal investigator, Translational Research Institute for Metabolism and DiabetesElizabeth Mayer-Davis, PhD, Principal investigator, UNC Chapel HillDavid M Maahs, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379792
- Sponsor's protocol ID
- TRIMDFH 1144866
- Acronym
- ACME
- Status last verified
- Apr 2023
- First submitted
- 15 Nov 2017
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25998289Chillaron 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.
PubMed 25413942Maahs 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.
PubMed 20820753Diabetes 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.
PubMed 19636033Jacob 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.
PubMed 16776747Rigalleau 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.
PubMed 15207844Carlson 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.
PubMed 8243815Greco 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.
PubMed 8586779Nair 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.
PubMed 6147290Casu 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.
PubMed 37576973Corbin 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.
PubMed 35460915
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03379792
- Acronym / sponsor ID
- ACME / TRIMDFH 1144866
- Conditions
- Type 1 Diabetes
- Keywords
- Obesity, Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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).
Key inclusion criteria (8 listed)
- Males and females, 19 to 30 years of age, inclusive.
- Type 1 Diabetes Cohort:
- Able to provide informed consent.
- BMI 18-39.9 kg/m^2
Key exclusion criteria (29 listed)
- Type 2 diabetes
- 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)
- Liver disease (AST or ALT >2.5 times the upper limit of normal), history of hepatitis
- Kidney disease (creatinine >1.6 mg/dl or estimated glomerular filtration rate (GFR)<60 ml/min)
- Dyslipidemia, including triglycerides >800 mg/dl, LDL >200 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Energy Expenditure
Time frame: 24 hours
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25998289Miller 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.
- Background: PubMed 25413942Chillaron 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.
- Background: PubMed 20820753Maahs 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.
- Background: PubMed 19636033Diabetes 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.
- Background: PubMed 16776747Jacob 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.
- Background: PubMed 15207844Rigalleau 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.
- Background: PubMed 8243815Carlson 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.
- Background: PubMed 8586779Greco 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.
- Background: PubMed 6147290Nair 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.
- Derived from this study: PubMed 37576973Casu 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.
- Derived from this study: PubMed 35460915Corbin 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.
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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.
Richard Pratley, MD principal investigator
Translational Research Institute for Metabolism and Diabetes
Elizabeth Mayer-Davis, PhD principal investigator
UNC Chapel Hill
David M Maahs, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by AdventHealth Translational Research Institute 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 8 inclusion and 29 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: finished, as of the sponsor's last update on 5 Jan 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?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Expenditure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03379792, which also lists 11 linked publications.
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 Jan 2024.