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Mitochondrial-related Platelet Transcript Expression Levels in Pre-diabetic Subjects Randomized to Metformin or Placebo (MAP-2)

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ClinicalTrials.gov Identifier: NCT02682121
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Matthew Rondina, MD, University of Utah

Brief Summary:

Diabetes mellitus (DM) imposes an approximate 2-fold increased risk of atherothrombosis. Patients with type 2 DM have a 2- to 4-fold increase in the risk of coronary artery disease (CAD) and atherothrombotic complications. Current evidence indicates that altered platelet function and "reactivity" are key determinants of arterial and venous thrombosis in metabolic syndromes. In addition, venous thrombosis and pulmonary embolism are associated with increased body mass index, a common feature of type 2 DM and the metabolic syndrome. Altered platelet behavior, function, and phenotype may be critical factors in these thrombotic complications as well. The mechanisms that lead to altered phenotype and function of platelets in DM, and that underlie heightened contributions of platelets to thrombotic complications in type 2 DM, are nevertheless incompletely understood. In this project, the investigators will prospectively determine if clinical intervention with metformin--a commonly-used therapeutic agent that reduces blood glucose, promotes weight loss, and improves lipid profiles--reverses platelet reprogramming and hyperreactivity in obese subjects with impaired fasting glucose and thus, at-risk for type 2 DM.

In addition to metformin, all participants will be given lifestyle modification (LSM) education on diet and physical activity, followed by guidance on how to adhere to the LSM, depending on random assignment to intervention group (education only (n=26) vs. implementation intentions alone (n=27) vs. implementation intentions with partner (n=27)). The LSM coaching for different intervention groups will allow the investigators to test whether there are more effective ways for adherence than others. Participants in these three LSM intervention groups will be further randomized to either Metformin (n=40) or Placebo (n=40), such that participants in the three LSM groups will be randomly and evenly distributed across the two study medication groups.


Condition or disease Intervention/treatment Phase
Prediabetes Drug: Metformin Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Metabolic Alterations in Platelet Study II
Study Start Date : April 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients on placebo.
Drug: Placebo
Placebo twice daily

Active Comparator: Active drug
Patients on Metformin, 850mg twice daily for 6mos.
Drug: Metformin
Metformin 850 mg twice daily




Primary Outcome Measures :
  1. The primary outcome will be gene expression levels of mitofusin 2 and uncoupling protein 2 [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age≥18 years
  • BMI>25 kg/m2
  • fasting plasma glucose 100-125 mg/dL, AND/OR Hemoglobin-A1C between 5.5 and 6.4%, AND/OR post-load glucose between 140 and 199 mg/dL on a 2-hour Oral Glucose Tolerance Test (OGTT)
  • All inclusion criteria will be checked on participants' first in-person visits.

Exclusion Criteria:

  • unwilling to accept treatment assignment by randomization
  • participation in another clinical research trial
  • history of myocardial infarction or stroke
  • significant arrhythmia (e.g. atrial fibrillation)
  • active thromboembolic disease
  • inflammatory bowel disease
  • serum creatinine levels greater than or equal to 1.5 mg/dL in males or greater than or equal to 1.4 mg/dL in females
  • known hypersensitivity to metformin hydrochloride or any of its components
  • acute or chronic metabolic acidosis
  • inability to participate in lifestyle modifications
  • pregnancy; other glucose-lowering or diabetic therapy
  • systemic glucocorticoids
  • prescription weight loss medications
  • or otherwise deemed unsuitable by study investigators (e.g. unable to complete follow-up visits, alcohol abuse, etc).

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): NCT02682121


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Andrew S Weyrich, PhD University of Utah
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Responsible Party: Matthew Rondina, MD, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT02682121    
Other Study ID Numbers: 1002
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs