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Prediabetes, Exercise, and Appetite Regulation (PEAR)

Primary Purpose

PreDiabetes, Appetitive Behavior

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Exercise
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PreDiabetes focused on measuring Resistance Exercise, Pre Diabetes, Appetite

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-50 years of age
  • BMI between 27-40 kg/m²
  • Hemoglobin A1c level between 5.7% and 6.4%
  • Physical Activity (less than 150 min/week moderate-intensity Physical Activity, no more than 1 session/week of resistance exercise)

Exclusion Criteria:

  • Unstable Cardiovascular Disease
  • Uncontrolled hypertension
  • Severe hypertriglyceridemia
  • History of or active liver disease
  • Uncontrolled thyroid disease
  • Active cancer diagnosis
  • Smoking
  • Engaged in exercise or diet program
  • History of bariatric surgery
  • GI malabsorptive disorders
  • Significant diet intolerances
  • History of major psychiatric disorder
  • presence of alcohol or substance abuse;
  • medications affecting weight,
  • EI or EE in past 6 months;
  • women currently pregnant, lactating, less than 6 months post-partum, or postmenopausal.

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Resistance Exercise

Arm Description

Resistance exercise will be training all major muscle groups 2x/week (2 days upper body, 2 days lower body) at 40-50% 1 repetition max (RM; estimated from 10 RM baseline testing) for 3 sets of 10-12 reps. This equals 4x/week for the 3 week intervention period.

Outcomes

Primary Outcome Measures

Changes in Appetite Rating
Hunger/Satiety before/after consumption of a meal
Changes in Hormonal Response to Feeding
Assessment of Ghrelin levels analyzed in blood samples before/after feeding.

Secondary Outcome Measures

Changes in Body Composition
Measured via BodPod
Changes in Maximal Strength
Measurement via 10 repetition-max testing.
Changes in Physical Activity Levels
Measured via ActivPal Monitor
Changes in Food-Related Behaviors
Evaluated via the Food Craving Inventory
Changes in Food-Related Behaviors
Evaluated via Three-Factor Eating Questionnaire
Changes in Food-Related Behaviors
Evaluated via the Weight Efficacy Lifestyle Questionnaire
Change in Ad libitum Energy Intake - In lab
In lab ad libitum buffet lunch (via weigh and measure methodology)
Changes in Ad libitum Energy Intake - Free Living
3 days of free-living ad libitum energy intake (via self-report)

Full Information

First Posted
April 19, 2021
Last Updated
October 13, 2022
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT04910763
Brief Title
Prediabetes, Exercise, and Appetite Regulation
Acronym
PEAR
Official Title
Alterations to Appetite Regulation Indices in Adults With Prediabetes Following Short-Term Aerobic vs. Resistance Exercise Training
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of institutional resources to conduct project, increased cost of conducting project due to workarounds with resources not being available, and COVID-19 pausing human subjects data collection in 2020.
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
September 3, 2021 (Actual)
Study Completion Date
September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to learn about how type of exercise influences measures of appetite regulation.
Detailed Description
The primary objective of this study is to understand the relationship between exercise modality and appetite regulation in a population with pre-diabetes. The study includes a screening visit to ensure eligibility of participants, baseline assessments, a resistance exercise intervention, and post intervention measurements. The variables of interest include, but are not limited to, hormonal responses to exercise training pertaining to appetite, food cravings, appetite ratings. activity levels, body composition, and ten repetition-max strength. The aim of this study is to better understand the mechanisms involved in the correlation or causation of any improvements in fitness and appetite regulation in a cohort with pre-diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Appetitive Behavior
Keywords
Resistance Exercise, Pre Diabetes, Appetite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants are randomly assigned to one of the two intervention groups.
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance Exercise
Arm Type
Experimental
Arm Description
Resistance exercise will be training all major muscle groups 2x/week (2 days upper body, 2 days lower body) at 40-50% 1 repetition max (RM; estimated from 10 RM baseline testing) for 3 sets of 10-12 reps. This equals 4x/week for the 3 week intervention period.
Intervention Type
Behavioral
Intervention Name(s)
Resistance Exercise
Intervention Description
Increasing strength and fitness and thereby influencing hormones and perceptions involved in appetite regulation.
Primary Outcome Measure Information:
Title
Changes in Appetite Rating
Description
Hunger/Satiety before/after consumption of a meal
Time Frame
Baseline: Pre-Meal , 30 minutes, 60 minutes, 90 minutes, and 120 minutes post meal / Post-intervention(Week 4) :Pre-Meal, 30 minutes, 60 minutes, 90 minutes ,and 120 minutes post meal
Title
Changes in Hormonal Response to Feeding
Description
Assessment of Ghrelin levels analyzed in blood samples before/after feeding.
Time Frame
Baseline: Pre-Meal , 30 minutes, 60 minutes, 90 minutes, and 120 minutes post meal / Post-intervention(Week 4) :Pre-Meal, 30 minutes, 60 minutes, 90 minutes ,and 120 minutes post meal
Secondary Outcome Measure Information:
Title
Changes in Body Composition
Description
Measured via BodPod
Time Frame
Baseline and Post-intervention(Week 4)
Title
Changes in Maximal Strength
Description
Measurement via 10 repetition-max testing.
Time Frame
Baseline and Post-intervention(Week 4)
Title
Changes in Physical Activity Levels
Description
Measured via ActivPal Monitor
Time Frame
Baseline and Post-intervention(Week 4)
Title
Changes in Food-Related Behaviors
Description
Evaluated via the Food Craving Inventory
Time Frame
Baseline and Post-intervention(Week 4)
Title
Changes in Food-Related Behaviors
Description
Evaluated via Three-Factor Eating Questionnaire
Time Frame
Baseline and Post-intervention(Week 4)
Title
Changes in Food-Related Behaviors
Description
Evaluated via the Weight Efficacy Lifestyle Questionnaire
Time Frame
Baseline and Post-intervention(Week 4)
Title
Change in Ad libitum Energy Intake - In lab
Description
In lab ad libitum buffet lunch (via weigh and measure methodology)
Time Frame
Baseline and Post-intervention(Week 4)
Title
Changes in Ad libitum Energy Intake - Free Living
Description
3 days of free-living ad libitum energy intake (via self-report)
Time Frame
Baseline and Post-intervention(Week 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-50 years of age BMI between 27-40 kg/m² Hemoglobin A1c level between 5.7% and 6.4% Physical Activity (less than 150 min/week moderate-intensity Physical Activity, no more than 1 session/week of resistance exercise) Exclusion Criteria: Unstable Cardiovascular Disease Uncontrolled hypertension Severe hypertriglyceridemia History of or active liver disease Uncontrolled thyroid disease Active cancer diagnosis Smoking Engaged in exercise or diet program History of bariatric surgery GI malabsorptive disorders Significant diet intolerances History of major psychiatric disorder presence of alcohol or substance abuse; medications affecting weight, EI or EE in past 6 months; women currently pregnant, lactating, less than 6 months post-partum, or postmenopausal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya M Halliday, PhD, RD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

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Prediabetes, Exercise, and Appetite Regulation

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