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Disease Prevention in Clinical Practice Base on Patient Specific Physiology (STOPDISEASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03308773
Recruitment Status : Enrolling by invitation
First Posted : October 13, 2017
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
John Armato, Pacific Coast Family Medical Group

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.


Condition or disease Intervention/treatment
PreDiabetes Insulin Resistance Type2 Diabetes NASH - Nonalcoholic Steatohepatitis Diastolic Dysfunction Dementia Atrial Fibrillation Cancer Atherosclerosis Carotid Plaque Other: Lifestyle modification in routine care of patients

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Physiology of Disease Prevention Observational Study in Clinical Practice
Actual Study Start Date : January 5, 2009
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Lifestyle modification in routine care of patients
    Diabetes Prevention Program Lifestyle recommendations and non-investigational pharmacotherapy in routine care of patients
    Other Name: non-investigational drug in routine care of patients


Primary Outcome Measures :
  1. Number of participants who develop type 2 diabetes based on response to oral glucose tolerance test [ Time Frame: 6 months and an average of every 2 years through the study completion, approximately 20 years ]
    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.

  2. Time to development of type 2 diabetes [ Time Frame: 6 months and an average of every 2 years through the study completion, approximately 20 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Internal Medicine/Endocrinology private practice in Southern California
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with prior treatment with medications for type 2 diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308773


Sponsors and Collaborators
Pacific Coast Family Medical Group
Investigators
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Principal Investigator: John P Armato, MD Providence St Josephs Health
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Armato, Physician, Principle investigator, Pacific Coast Family Medical Group
ClinicalTrials.gov Identifier: NCT03308773    
Other Study ID Numbers: 2017000308
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Armato, Pacific Coast Family Medical Group:
Prediabetes
insulin resistance
T2DM
Carotid IMT/Plaque
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Atrial Fibrillation
Atherosclerosis
Insulin Resistance
Prediabetic State
Glucose Intolerance
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Liver Diseases
Digestive System Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia