Disease Prevention in Clinical Practice Base on Patient Specific Physiology

NCT03308773 | Enrolling By Invitation

• 1 other identifier: 2017000308
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is well known that the Type 2 diabetes and vascular disease are preceded by over ten years by metabolic dysfunction and anatomic changes that can be quantified. In order to develop effective preventive strategies and reduce the cost burden to the health care system, recognition of the earliest pathophysiology of Type 2 diabetes and vascular disease is clinically relevant. The interval retrospective evaluation of data from patient records, reflect the effectiveness of the various treatments implemented in clinical practice. Prevalence of "prediabetes" among American adults is estimated to be \~84 million, or one out of three Americans. Over a 5-7 year period approximately one third of these prediabetic individuals will progress to type 2 diabetes. Prediabetes is a heterogenous group comprised of individuals with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and increased A1c (5.7-6.4%). Although different pathophysiologies are present in individuals with IFG and IGT, their conversion rate to overt type 2 diabetes mellitus (T2DM) is similar. Insulin resistance is a common causal feature of many of the pathophysiologic mechanisms linking macrovascular disease and type 2 diabetes. Because hyperglycemia is the major factor responsible for the development of microvascular complications, it logically follows that prevention of progression of prediabetes to overt diabetes should retard/prevent the development of the microvascular complications. From the measurement of plasma glucose, insulin, and c-peptide levels during the oral glucose tolerance test, one can derive measures of the two core defects responsible for the development of T2DM, i.e. insulin resistance and beta cell dysfunction as well as the degree of dysglycemia. By combining a standard medical evaluation with the evaluation of cardiovascular biomarkers, patients at intermediate risk of vascular disease can be identified. In these patients, carotid intima media thickness (IMT) and carotid plaque evaluation is offered to attempt to clarify risk. The hypothesis of this observational study is that the characterization of the physiology and anatomy of patients at risk of developing type 2 diabetes and/or cardiovascular disease can stratify risk of developing disease and direct treatment strategies tailored to the identified physiologic defect, leading to improvements in the delay or prevention of disease.

Conditions

PreDiabetes; Insulin Resistance; Type2 Diabetes; NASH - Nonalcoholic Steatohepatitis; Diastolic Dysfunction; Dementia; Atrial Fibrillation; Cancer; Atherosclerosis; Carotid Plaque

Keywords

Prediabetes; insulin resistance; T2DM; Carotid IMT/Plaque

Outcome Measures

Primary Outcomes (2)

• Number of participants who develop type 2 diabetes based on response to oral glucose tolerance test

  Patients will be monitored for up to 20 years (10 year retrospective plus 10 year prospective). The outcome measure will reflect the number of patients who develop of type 2 diabetes as evidenced by the response to oral glucose tolerance testing.

  6 months and an average of every 2 years through the study completion, approximately 20 years

• Time to development of type 2 diabetes

  Patients will be monitored for up to 20 years (10 year retrospective plus 10 year prospective). The outcome measure will reflect the time to the development of type 2 diabetes as evidenced by the response to oral glucose tolerance testing.

  6 months and an average of every 2 years through the study completion, approximately 20 years

Interventions

Lifestyle modification in routine care of patients OTHER

Diabetes Prevention Program Lifestyle recommendations and non-investigational pharmacotherapy in routine care of patients

Also known as: non-investigational drug in routine care of patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Internal Medicine/Endocrinology private practice in Southern California

You may qualify if:

• American Diabetic Association (ADA)/American Association of Clinical Endocrinologists (AACE) criteria for patients at risk for developing type 2 diabetes

You may not qualify if:

• Patients with prior treatment with medications for type 2 diabetes

Sponsors & Collaborators

• Pacific Coast Family Medical Group: lead

Related Publications (11)

• Menke A, Casagrande S, Geiss L, Cowie CC. Prevalence of and Trends in Diabetes Among Adults in the United States, 1988-2012. JAMA. 2015 Sep 8;314(10):1021-9. doi: 10.1001/jama.2015.10029.

  PMID: 26348752 BACKGROUND

• Abdul-Ghani MA, Tripathy D, DeFronzo RA. Contributions of beta-cell dysfunction and insulin resistance to the pathogenesis of impaired glucose tolerance and impaired fasting glucose. Diabetes Care. 2006 May;29(5):1130-9. doi: 10.2337/diacare.2951130.

  PMID: 16644654 BACKGROUND

• Abdul-Ghani MA, Jenkinson CP, Richardson DK, Tripathy D, DeFronzo RA. Insulin secretion and action in subjects with impaired fasting glucose and impaired glucose tolerance: results from the Veterans Administration Genetic Epidemiology Study. Diabetes. 2006 May;55(5):1430-5. doi: 10.2337/db05-1200.

  PMID: 16644701 BACKGROUND

• Diabetes Prevention Program Research Group. The prevalence of retinopathy in impaired glucose tolerance and recent-onset diabetes in the Diabetes Prevention Program. Diabet Med. 2007 Feb;24(2):137-44. doi: 10.1111/j.1464-5491.2007.02043.x.

  PMID: 17257275 BACKGROUND

• DREAM Trial Investigators; Dagenais GR, Gerstein HC, Holman R, Budaj A, Escalante A, Hedner T, Keltai M, Lonn E, McFarlane S, McQueen M, Teo K, Sheridan P, Bosch J, Pogue J, Yusuf S. Effects of ramipril and rosiglitazone on cardiovascular and renal outcomes in people with impaired glucose tolerance or impaired fasting glucose: results of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial. Diabetes Care. 2008 May;31(5):1007-14. doi: 10.2337/dc07-1868. Epub 2008 Feb 11.

  PMID: 18268075 BACKGROUND

• Asghar O, Petropoulos IN, Alam U, Jones W, Jeziorska M, Marshall A, Ponirakis G, Fadavi H, Boulton AJ, Tavakoli M, Malik RA. Corneal confocal microscopy detects neuropathy in subjects with impaired glucose tolerance. Diabetes Care. 2014 Sep;37(9):2643-6. doi: 10.2337/dc14-0279. Epub 2014 Jun 26.

  PMID: 24969581 BACKGROUND

• Gibbons CH, Goebel-Fabbri A. Microvascular Complications Associated With Rapid Improvements in Glycemic Control in Diabetes. Curr Diab Rep. 2017 Jul;17(7):48. doi: 10.1007/s11892-017-0880-5.

  PMID: 28526993 BACKGROUND

• Defronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009 Apr;58(4):773-95. doi: 10.2337/db09-9028. No abstract available.

  PMID: 19336687 BACKGROUND

• Armato J, DeFronzo RA, Abdul-Ghani M, Ruby R. Successful treatment of prediabetes in clinical practice: targeting insulin resistance and beta-cell dysfunction. Endocr Pract. 2012 May-Jun;18(3):342-50. doi: 10.4158/EP11194.OR.

  PMID: 22068250 BACKGROUND

• Huang Y, Cai X, Mai W, Li M, Hu Y. Association between prediabetes and risk of cardiovascular disease and all cause mortality: systematic review and meta-analysis. BMJ. 2016 Nov 23;355:i5953. doi: 10.1136/bmj.i5953.

  PMID: 27881363 BACKGROUND

• Armato JP, DeFronzo RA, Abdul-Ghani M, Ruby RJ. Successful treatment of prediabetes in clinical practice using physiological assessment (STOP DIABETES). Lancet Diabetes Endocrinol. 2018 Oct;6(10):781-789. doi: 10.1016/S2213-8587(18)30234-1. Epub 2018 Sep 14.

  PMID: 30224284 DERIVED

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Non-alcoholic Fatty Liver Disease; Dementia; Atrial Fibrillation; Neoplasms; Atherosclerosis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Fatty Liver; Liver Diseases; Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• John P Armato, MD

  Providence St Josephs Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Principle investigator

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 13, 2017
• Study Start: January 5, 2009
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share