Prediabetes, Exercise, and Appetite Regulation (PEAR)

Alterations to Appetite Regulation Indices in Adults With Prediabetes Following Short-Term Aerobic vs. Resistance Exercise Training

The purpose of the study is to learn about how type of exercise influences measures of appetite regulation.

Study Overview

• Status: Terminated
• Conditions: PreDiabetes; Appetitive Behavior
• Intervention / Treatment: Behavioral: Resistance Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistance Exercise; 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.	Behavioral: Resistance Exercise; Increasing strength and fitness and thereby influencing hormones and perceptions involved in appetite regulation.

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure	Measure Description	Time Frame
Changes in Body Composition	Measured via BodPod	Baseline and Post-intervention(Week 4)
Changes in Maximal Strength	Measurement via 10 repetition-max testing.	Baseline and Post-intervention(Week 4)
Changes in Physical Activity Levels	Measured via ActivPal Monitor	Baseline and Post-intervention(Week 4)
Changes in Food-Related Behaviors	Evaluated via the Food Craving Inventory	Baseline and Post-intervention(Week 4)
Changes in Food-Related Behaviors	Evaluated via Three-Factor Eating Questionnaire	Baseline and Post-intervention(Week 4)
Changes in Food-Related Behaviors	Evaluated via the Weight Efficacy Lifestyle Questionnaire	Baseline and Post-intervention(Week 4)
Change in Ad libitum Energy Intake - In lab	In lab ad libitum buffet lunch (via weigh and measure methodology)	Baseline and Post-intervention(Week 4)
Changes in Ad libitum Energy Intake - Free Living	3 days of free-living ad libitum energy intake (via self-report)	Baseline and Post-intervention(Week 4)

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Tanya M Halliday, PhD, RD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Actual): September 3, 2021
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Appetite; Resistance Exercise; Pre Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 000116248

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No