Prediabetes, Exercise, and Appetite Regulation

PreDiabetes Clinical Trial

— PEAR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04910763
• Other study ID #: 000116248
• Status: Terminated
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: September 28, 2022

Study information

• Verified date: October 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: September 28, 2022
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appetitive Behavior
• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Resistance Exercise
Increasing strength and fitness and thereby influencing hormones and perceptions involved in appetite regulation.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in Body Composition	Measured via BodPod	Baseline and Post-intervention(Week 4)
Secondary	Changes in Maximal Strength	Measurement via 10 repetition-max testing.	Baseline and Post-intervention(Week 4)
Secondary	Changes in Physical Activity Levels	Measured via ActivPal Monitor	Baseline and Post-intervention(Week 4)
Secondary	Changes in Food-Related Behaviors	Evaluated via the Food Craving Inventory	Baseline and Post-intervention(Week 4)
Secondary	Changes in Food-Related Behaviors	Evaluated via Three-Factor Eating Questionnaire	Baseline and Post-intervention(Week 4)
Secondary	Changes in Food-Related Behaviors	Evaluated via the Weight Efficacy Lifestyle Questionnaire	Baseline and Post-intervention(Week 4)
Secondary	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)
Secondary	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)