Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
80 participants
Study Classification
OBSERVATIONAL
Study Start Date
2010-11-30
Study Completion Date
2014-06-30
Brief Summary
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This is a study to identify different subtypes of type 2 diabetes. The investigators will look for information at the molecular level, which may lead to personalized diagnosis and therapies.
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Detailed Description
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Type 2 diabetes mellitus (T2DM) is approaching epidemic prevalence in the US adult population (over 1 in 10 of all US adults over 20). Diabetes is diagnosed based on fasting hyperglycemia, oral glucose intolerance or markers of hyperglycemia such as HbA1c. However, we now recognize that diabetes is a heterogeneous disorder. With the existing overly simplistic diagnostic criteria, treatment failure rates are high for virtually every agent currently in the drug arsenal - including insulin. In the late 1990's oncologists pioneered the use of high-throughput molecular technologies, such as transcriptome profiling and more recently metabolomics to identify discrete sub-classes of cancers that cannot be distinguished histologically or by a small number of biochemical markers. That effort rapidly accelerated the pace of scientific discovery and quickly led to the development of personalized cancer therapeutics. We believe that those cancer efforts provide a roadmap for biomarker discovery and personalized therapy in diabetes. molecular phenotyping (profiling the metabolome, transcriptome, and epigenome) with advanced bioinformatics analysis will identify discrete subtypes of diabetes - ushering in a new era of personalized diagnosis and therapy in diabetes.
Conditions
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Type 2 Diabetes
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Non-Diabetic Lean Athletes
Athletes with a Body Mass Index (BMI) less than or equal to 25 kg/m2.
No interventions assigned to this group
Non-Diabetic Lean No Diabetes History
Adults with a BMI \< 25 kg/m2 and no family history of diabetes
No interventions assigned to this group
Non-Diabetic Lean Yes Diabetes History
Adults with a BMI \< 25 kg/m2 and family history of diabetes
No interventions assigned to this group
Non-Diabetic Obese
Adults with BMI greater than or equal to 30 kg/m2.
No interventions assigned to this group
Non-Diabetic Obese Female PCOS
Female adults with BMI \> 30 kg/m2 and Polycystic Ovarian Syndrome (PCOS).
No interventions assigned to this group
Diabetic No Medication
Have diabetes and currently receiving no medication or early treatment with one medication. Some participants receiving insulin may also be included in this study
No interventions assigned to this group
Diabetic GAD Ab+
Have diabetes with Latent Autoimmune Diabetes in Adults (LADA).
No interventions assigned to this group
Diabetic With NASH
Have diabetes with Nonalcoholic Steatohepatitis (NASH), which is chronic liver disease with fat in the liver, inflammation, and damage not associated with drinking alcohol.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age \> 18
* HbA1C \< 8.0% \*
* You have not gained or lost more than 3 kg or 6.6 pounds in the last 8 weeks
* You have not lost more than 10% of your heaviest body weight in your lifetime
* BMI \< 25 kg/m2 or \> 30 kg/m2
* Women: more than 1 year post-partum
* Have diabetes and are able to maintain accurate and reliable home glucose monitoring logs
* HbA1C \< 8.0% \*
* You have not gained or lost more than 3 kg or 6.6 pounds in the last 8 weeks
* You have not lost more than 10% of your heaviest body weight in your lifetime
* BMI \< 25 kg/m2 or \> 30 kg/m2
* Women: more than 1 year post-partum
* Have diabetes and are able to maintain accurate and reliable home glucose monitoring logs
Exclusion Criteria
* Treatment with more than 2 of the following: metformin (Fortamet, Glucophage, Glumetza, Riomet), sulfonylureas (Glucotrol, Diabeta, Glynase, Micronase), Glucagon-like peptide-1 analogs (Byetta) and/or Dipeptidyl peptidase IV inhibitors (Januvia, Onglyza)
* Treatment with long acting Glucagon-like peptide-1 agonists within the last 3 months (i.e. exenatide once weekly)
* Treatment with thiazolidinediones (TZDs) (i.e. Avandia, Actos, Rezulin) within the last 3 months
* Known, untreated thyroid disease or abnormal thyroid function blood test.\*
* Known diagnosis of liver disease (except NASH) or elevated liver function blood test
* Known diagnosis of kidney disease or elevated kidney function blood test
* Uncontrolled high blood pressure (BP \> 140 systolic or \> 90 diastolic)
* Start of or changes in oral contraceptives or hormone replacement therapy within the last 3 months
* Use of drugs or alcohol (\> 3 drinks per day) within the last 5 years.
* Uncontrolled psychiatric disease that would interfere with study participation.
* History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable)
* History of organ transplant
* History of heart attack within the last 6 months
* Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for testing procedures
* Current anemia
* History of HIV, active Hepatitis B or C, or Tuberculosis
* Presence of clinically significant abnormalities on electrocardiogram.
* Current smokers (smoking any nicotine or non-nicotine product within the past 3 months)
* Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids \[steroids\], etc.)
* Treatment with long acting Glucagon-like peptide-1 agonists within the last 3 months (i.e. exenatide once weekly)
* Treatment with thiazolidinediones (TZDs) (i.e. Avandia, Actos, Rezulin) within the last 3 months
* Known, untreated thyroid disease or abnormal thyroid function blood test.\*
* Known diagnosis of liver disease (except NASH) or elevated liver function blood test
* Known diagnosis of kidney disease or elevated kidney function blood test
* Uncontrolled high blood pressure (BP \> 140 systolic or \> 90 diastolic)
* Start of or changes in oral contraceptives or hormone replacement therapy within the last 3 months
* Use of drugs or alcohol (\> 3 drinks per day) within the last 5 years.
* Uncontrolled psychiatric disease that would interfere with study participation.
* History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable)
* History of organ transplant
* History of heart attack within the last 6 months
* Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for testing procedures
* Current anemia
* History of HIV, active Hepatitis B or C, or Tuberculosis
* Presence of clinically significant abnormalities on electrocardiogram.
* Current smokers (smoking any nicotine or non-nicotine product within the past 3 months)
* Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids \[steroids\], etc.)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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AdventHealth
OTHER
Sponsor Role
collaborator
Sanford-Burnham Medical Research Institute
OTHER
Sponsor Role
collaborator
UCSF Benioff Children's Hospital Oakland
OTHER
Sponsor Role
collaborator
Duke Univeristy Sarah W. Stedman Nutrition & Metabolism Center
UNKNOWN
Sponsor Role
collaborator
AdventHealth Translational Research Institute
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Steven R Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Translational Research Institute for Metabolism and Diabetes
Locations
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Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States
Site Status
Countries
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United States
References
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Divoux A, Eroshkin A, Erdos E, Sandor K, Osborne TF, Smith SR. DNA Methylation as a Marker of Body Shape in Premenopausal Women. Front Genet. 2021 Jul 29;12:709342. doi: 10.3389/fgene.2021.709342. eCollection 2021.
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Pachori AS, Madan M, Nunez Lopez YO, Yi F, Meyer C, Seyhan AA. Reduced skeletal muscle secreted frizzled-related protein 3 is associated with inflammation and insulin resistance. Obesity (Silver Spring). 2017 Apr;25(4):697-703. doi: 10.1002/oby.21787. Epub 2017 Feb 27.
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Related Links
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http://www.tri-md.org
Florida Hospital Translational Research Institute for Metabolism and Diabetes
Other Identifiers
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TRIMDFH 238153
Identifier Type: -
Identifier Source: org_study_id
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