Prediabetes, Exercise, and Appetite Regulation

Study Overview
=================
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.

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

Conditions
-----------------
Appetitive Behavior, PreDiabetes

Intervention / Treatment
-----------------
* Behavioral: Resistance Exercise


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Participants are randomly assigned to one of the two intervention groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance Exercise<br>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<br>* Increasing strength and fitness and thereby influencing hormones and perceptions involved in appetite regulation.<br>|

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistance Exercise, Pre Diabetes, Appetite