Type 1 Diabetes
Conditions
Keywords
Obesity, Overweight
Brief 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.
Interventions
None listed
Sponsors
AdventHealth Translational Research Institute
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
19 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females, 19 to 30 years of age, inclusive. 2. Type 1 Diabetes Cohort: 1. Diagnosis of type 1 diabetes for greater than 1 year at screening. 2. Hemoglobin A1c 6.5-13% or Control Cohort Without Diabetes: a. Healthy individuals without diabetes matched to T1D cohort by BMI and gender 3. Able to provide informed consent. 4. BMI 18-39.9 kg/m\^2
Exclusion criteria
1. Type 2 diabetes 2. 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) 3. Liver disease (AST or ALT \>2.5 times the upper limit of normal), history of hepatitis 4. Kidney disease (creatinine \>1.6 mg/dl or estimated glomerular filtration rate (GFR)\<60 ml/min) 5. Dyslipidemia, including triglycerides \>800 mg/dl, LDL \>200 mg/dl 6. Anemia (hemoglobin \<12 g/dl in men, \<11 g/dl in women) 7. Thyroid dysfunction (suppressed thyroid-stimulating hormone (TSH), elevated TSH \<10 µIU/ml if symptomatic or elevated TSH \>10 µIU/ml if asymptomatic) 8. Uncontrolled hypertension (BP \>160 mmHg systolic or \> 100mmHg diastolic) 9. History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable). 10. 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) 11. History of organ transplant 12. History of HIV, active Hepatitis B or C, or Tuberculosis 13. Pregnancy, lactation or 6 months postpartum from screening visit 14. History of major depression 15. Psychiatric disease prohibiting adherence to study protocol 16. History of eating disorders 17. Cushing's disease or syndrome 18. History of bariatric surgery 19. Tobacco use within the past 3 months 20. History of drug or alcohol abuse (≥3 drinks per day) within the last 5 years 21. Use of oral or injectable anti-hyperglycemic agents (except insulin) 22. Current use of beta-adrenergic blocking agents 23. Use of antibiotics within the past 3 months 24. Weight \>450 lbs (This is DEXA table weight limit) 25. Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at screening 26. Unable to participate in MRI or magnetic resonance spectroscopy (MRS) assessment based on Investigator's judgment at screening 27. 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) 28. 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. 29. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Energy Expenditure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Type 1 Diabetes: BMI Classified as Lean Participants with type 1 diabetes with a BMI between 18.0-24.9 kg/m\^2. | 6 |
| Type 1 Diabetes: BMI Classified as Overweight Participants with type 1 diabetes with a BMI between 25.0-29.9 kg/m\^2. | 9 |
| Type 1 Diabetes: BMI Classified as Obese Participants with type 1 diabetes with a BMI between 30.0-39.9 kg/m\^2. | 5 |
| Control: BMI Classified as Lean Control participants without diabetes with a BMI between 18.0-24.9 kg/m\^2. | 4 |
| Control: BMI Classified as Overweight Control participants without diabetes with a BMI between 25.0-29.9 kg/m\^2. | 4 |
| Control: BMI Classified as Obese Control participants without diabetes with a BMI between 30.0-39.9 kg/m\^2. | 4 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Type 1 Diabetes: BMI Classified as Lean | Total | Control: BMI Classified as Obese | Control: BMI Classified as Overweight | Control: BMI Classified as Lean | Type 1 Diabetes: BMI Classified as Obese | Type 1 Diabetes: BMI Classified as Overweight |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 22.1 years STANDARD_DEVIATION 1.9 | 24.6 years STANDARD_DEVIATION 3.6 | 27.8 years STANDARD_DEVIATION 6.1 | 24.0 years STANDARD_DEVIATION 2.1 | 24.3 years STANDARD_DEVIATION 3.3 | 25.8 years STANDARD_DEVIATION 3.5 | 24.6 years STANDARD_DEVIATION 3.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 14 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 16 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 22 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 6 Participants |
| Region of Enrollment United States | 6 participants | 32 participants | 4 participants | 4 participants | 4 participants | 5 participants | 9 participants |
| Sex: Female, Male Female | 4 Participants | 15 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 17 Participants | 3 Participants | 3 Participants | 1 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 9 | 0 / 5 | 0 / 4 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 2 / 6 | 5 / 9 | 1 / 5 | 0 / 4 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 9 | 0 / 5 | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes: BMI Classified as Lean | Energy Expenditure | 1978.3 Kilocalories | Standard Deviation 337.8 |
| Type 1 Diabetes: BMI Classified as Overweight | Energy Expenditure | 1969.8 Kilocalories | Standard Deviation 236.3 |
| Type 1 Diabetes: BMI Classified as Obese | Energy Expenditure | 2414.8 Kilocalories | Standard Deviation 419.1 |
| Control: BMI Classified as Lean | Energy Expenditure | 1497.7 Kilocalories | Standard Deviation 123.6 |
| Control: BMI Classified as Overweight | Energy Expenditure | 1902.0 Kilocalories | Standard Deviation 406 |
| Control: BMI Classified as Obese | Energy Expenditure | 2671.3 Kilocalories | Standard Deviation 402.7 |
p-value: 0.24t-test, 2 sided
p-value: 0.22t-test, 2 sided
p-value: 1t-test, 2 sided