Uncovering the 'ORIGINS' of Diabetes

NCT02226640 | Completed DMC

• 1 other identifier: TRIMDFH 238153
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Perform 'deep' clinical and molecular phenotyping of 360 adults- Diabetic and Non-Diabetic

  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

Study Arms (8)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Related Publications (32)

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  BACKGROUND

• 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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Related Links

• Florida Hospital Translational Research Institute for Metabolism and Diabetes

Biospecimen

Retention: SAMPLES WITH DNA

Blood Urine Fat tissue Muscle Tissue

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Steven R Smith, MD

  Translational Research Institute for Metabolism and Diabetes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: August 27, 2014
• Study Start: November 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

US (1)