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MINDD 3: Prediabetes and Delay Discounting (MINDD)

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ClinicalTrials.gov Identifier: NCT03664726
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
Leonard Epstein, State University of New York at Buffalo

Brief Summary:
The proposed research will translate research on delay discounting to the prevention of Type 2 diabetes (T2D) in persons with prediabetes. In this study, the investigators will verify target engagement (DD) by examining if EFT improves DD under conditions shown to increase discounting of the future. Prediabetics will be randomized to receive EFT/ERT in a factorial design when experiencing simulated poverty/neutral conditions, respectively. The effects will be measured on DD. The investigators predict that poverty conditions will increase discounting of the future for ERT subjects, but those receiving EFT will show levels of DD similar to levels observed for participants in the wealth condition.

Condition or disease Intervention/treatment Phase
PreDiabetes Behavioral: Episodic Future Thinking Behavioral: Episodic Recent Thinking Not Applicable

Detailed Description:

The prevention of Type 2 diabetes in an obese person with prediabetes requires developing a healthier lifestyle. The rational approach for someone with prediabetes would be to eat healthier, be more active, lose weight, and manage their comorbidities. However, preliminary research suggests that individuals with Type 2 diabetes discount the future and engage in behaviors that maximize current pleasure and short-term gain; thus, daily choices needed to improve future health are rare in this population. Delay discounting (DD) describes the choice of smaller immediate versus larger delayed rewards. This behavioral process is related to a wide variety of health choices, ranging from preventive health to behavioral and medical regimen adherence, including regimens used for Type 2 diabetes. The investigators believe that DD provides a target for one type of self-regulation that can improve a wide variety of health behaviors and medical adherence.

Research from our laboratories has shown that episodic future thinking (EFT), a form of prospection which reduces the bias towards immediate gratification, activates brain regions involved in planning and prospection such that future rewards have increased value and the extent of delay discounting is reduced. Cueing individuals to think about future events during inter-temporal decision-making reduces the rate of DD, eating in and outside of the laboratory, and smoking behavior. The overarching goal of this research is to use an experimental medicine approach to translate basic research on DD and EFT into clinical interventions to prevent the transition from prediabetes to a diagnosis of Type 2 diabetes.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to complete an episodic future or recent thinking task and asked to describe positive events for different time periods.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Delay Discounting as a Target for Self-Regulation in Prediabetes
Actual Study Start Date : February 12, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Episodic Future Thinking (EFT)
Participants will complete an episodic thinking task to generate episodic cues where they will list and describe events for different time periods.The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event (e.g., vacations, weddings, parties, and so forth). EFT participants will list positive future events they are looking forward to and list events that could happen at different general future time points (e.g., 1 month, 2-6 months, 7-12 months)
Behavioral: Episodic Future Thinking
Participants will be instructed to use their episodic cues as they engage in different decision making tasks
Other Name: EFT

Active Comparator: Episodic Recent Thinking (ERT)
Participants will complete an episodic task to generate episodic cues where they will list and describe events for different time periods.The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event (e.g., vacations, weddings, parties). ERT participants will list positive recent events that have already happened and that they have enjoyed, at different general recent time points (e.g., a few hours ago, 1 day ago, 2-6 days ago, 7-12 days ago)
Behavioral: Episodic Recent Thinking
Participants will be instructed to use their episodic cues as they engage in different decision making tasks
Other Name: ERT




Primary Outcome Measures :
  1. Change in Delay Discounting [ Time Frame: Delay Discounting will be measured at baseline (session 1) and after receiving EFT/ERT intervention (up to 2 weeks post-baseline) ]
    Delay Discounting will be measured using gold standard monetary Delay Discounting tasks

  2. Change in Working Memory [ Time Frame: Working Memory will be measured at baseline (session 1) and after receiving EFT/ERT intervention (up to 2 weeks post-baseline) ]
    Backwards Corsi is a task that assesses visuo-spatial short term working memory


Secondary Outcome Measures :
  1. Relative Reinforcing Efficacy: Food Purchase Task [ Time Frame: Food Purchase Task will be measured at baseline (session 1) and after receiving EFT/ERT intervention (up to 2 weeks post-baseline) ]
    Changes in the RRE of food will be measured by a food purchase task, in which participants purchase quantities of their preferred food across a range of prices

  2. Blood Glucose [ Time Frame: Blood glucose will be measured at baseline (at the beginning of the session), 30 minutes after eating preload, and again at the end of the session (about 120 minutes after first measure) at both sessions 1 and 2 ]
    Blood glucose will be collected using the Freestyle Lite Blood glucose monitor



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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:

  • Prediabetes: Participants must have a diagnosis of prediabetes within the last 2 years or meet criteria for prediabetes. The American Diabetes Association guidelines defines prediabetes as Fasting Plasma Glucose (FPG) 100-125 mg/dl, 2h glucose 140-199 mg/dl after Oral Glucose Tolerance Test (OGTT), or hemoglobin A1c (HbA1c) approximately 5.7-6.4%.
  • Comorbidities: Participants must have a history of comorbid diagnosis such as hypertension and/or hyperlipidemia to participate in the behavioral portion of this study. Hypertension is defined as blood pressure greater than 140/90 on two separate occasions at least one week apart, or medical management for hypertension (i.e. medications including Lisinopril and Diovan). Dyslipidemia is defined by LDL greater than 130 mg/dl, or non-fasting non HDL cholesterol ≥160mg/dL or medical management for dyslipidemia (medications including Niacin, Lovastatin).

Exclusion Criteria:

  • Type 2 Diabetes: Individuals will be excluded if they have Type 2 Diabetes.
  • Pregnancy: Women who are pregnant or lactating will be excluded from participation.
  • Conditions that affect adherence: Participants should not have a condition that would limit participation which include medical conditions that would affect individuals' ability to use the computer for prolonged period of time; leave the individual unable to ambulate; or current diagnoses of an eating disorder (anorexia, bulimia,), unmanaged psychiatric disorder (depression, anxiety, attention deficit hyperactivity disorder (ADHD), schizophrenia), or an intellectual impairment that would impact study adherence.
  • Abnormal glucose related to medications: Participants should not be taking medications that would limit participation and cause abnormal glucose levels (e.g. atypical antipsychotic medications or glucocorticoids) including diabetic drugs such as Metformin.
  • Unwilling or unable to eat study food: Participants who are unwilling or not able to eat the study food (a PowerBar) will not be able to take part in this study.

Prior participation in similar studies: Individuals who have recently participated in a laboratory study using similar methods may also be excluded.

  • Do not meet discounting criteria: Individuals who do not meet discounting criteria (e.g. nonsystematic discounting) on a delay discounting task may be excluded.

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): NCT03664726


Locations
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United States, New York
University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine
Buffalo, New York, United States, 14214
Sponsors and Collaborators
Leonard Epstein
Virginia Polytechnic Institute and State University
Investigators
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Principal Investigator: Leonard H Epstein SUNY University at Buffalo
Principal Investigator: Warren K Bickel Virginia Polytechnic Institute and State University

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Responsible Party: Leonard Epstein, Principal Investigator, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT03664726     History of Changes
Other Study ID Numbers: UH2DK109543-02 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available

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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 Leonard Epstein, State University of New York at Buffalo:
Delay Discounting, Episodic Future Thinking

Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia