Uncovering the 'ORIGINS' of Diabetes (ORIGINS)

February 21, 2018 updated by: AdventHealth Translational Research Institute
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Community sample

Description

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

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Non-Diabetic Lean Athletes
Athletes with a Body Mass Index (BMI) less than or equal to 25 kg/m2.
Non-Diabetic Lean No Diabetes History
Adults with a BMI < 25 kg/m2 and no family history of diabetes
Non-Diabetic Lean Yes Diabetes History
Adults with a BMI < 25 kg/m2 and family history of diabetes
Non-Diabetic Obese
Adults with BMI greater than or equal to 30 kg/m2.
Non-Diabetic Obese Female PCOS
Female adults with BMI > 30 kg/m2 and Polycystic Ovarian Syndrome (PCOS).
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
Diabetic GAD Ab+
Have diabetes with Latent Autoimmune Diabetes in Adults (LADA).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perform 'deep' clinical and molecular phenotyping of 360 adults- Diabetic and Non-Diabetic
Time Frame: up to Day 9
Phenotyping will include whole body composition (DEXA), substrate metabolism, classic diabetes phenotypes, and detailed molecular phenotyping of circulating mononuclear cells/ plasma, muscle and adipose tissue.
up to Day 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Collaborators

AdventHealth
Sanford-Burnham Medical Research Institute
UCSF Benioff Children's Hospital Oakland
Duke Univeristy Sarah W. Stedman Nutrition & Metabolism Center

Investigators

  • Principal Investigator: Steven R Smith, MD, Translational Research Institute for Metabolism and Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIMDFH 238153

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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