Clinical trial NCT04910763: Prediabetes, Exercise, and Appetite Regulation
Official title: Alterations to Appetite Regulation Indices in Adults With Prediabetes Following Short-Term Aerobic vs. Resistance Exercise Training
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PreDiabetes
Appetitive Behavior
Keywords: Resistance Exercise
Pre Diabetes
Appetite
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are randomly assigned to one of the two intervention groups.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in Appetite Rating
timeFrame: 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
measure: Changes in Hormonal Response to Feeding
timeFrame: 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 outcomes:
measure: Changes in Body Composition
timeFrame: Baseline and Post-intervention(Week 4)
measure: Changes in Maximal Strength
timeFrame: Baseline and Post-intervention(Week 4)
measure: Changes in Physical Activity Levels
timeFrame: Baseline and Post-intervention(Week 4)
measure: Changes in Food-Related Behaviors
timeFrame: Baseline and Post-intervention(Week 4)
measure: Changes in Food-Related Behaviors
timeFrame: Baseline and Post-intervention(Week 4)
measure: Changes in Food-Related Behaviors
timeFrame: Baseline and Post-intervention(Week 4)
measure: Change in Ad libitum Energy Intake - In lab
timeFrame: Baseline and Post-intervention(Week 4)
measure: Changes in Ad libitum Energy Intake - Free Living
timeFrame: Baseline and Post-intervention(Week 4)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Tanya M Halliday, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: