Prediabetes, Exercise, and Appetite Regulation

Not Applicable

Terminated

• Conditions: Appetitive Behavior; PreDiabetes

• Registration Number: NCT04910763
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study Start: 2019-06-12
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-02
• Primary Completion: 2021-09-03
• Study Completion: 2022-09-28
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States