PreDiabetesPEARNCT04910763
Prediabetes, Exercise, and Appetite Regulation
A study testing Resistance Exercise in people with PreDiabetes and Appetitive Behavior, run by University of Utah at 1 site in United States.
Trial summary
The purpose of the study is to learn about how type of exercise influences measures of appetite regulation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Appetitive Behavior
- What is being tested?
- Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 28 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Unstable Cardiovascular Disease
- Uncontrolled hypertension
- Severe hypertriglyceridemia
- History of or active liver disease
- Uncontrolled thyroid disease
- Active cancer diagnosis
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- PreDiabetes, Appetitive Behavior
- Being tested
- Resistance Exercise
- Keywords
- Resistance Exercise, Pre Diabetes, Appetite
- Medical subject headings
- Prediabetic State, Appetitive Behavior, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
Increasing strength and fitness and thereby influencing hormones and perceptions involved in appetite regulation.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise | Experimental | 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. Receives: Behavioral: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Appetite Rating
Hunger/Satiety before/after consumption of a meal
Measured: 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.
Measured: 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 (8)
Changes in Body Composition
Measured via BodPod
Measured: Baseline and Post-intervention(Week 4)
Changes in Maximal Strength
Measurement via 10 repetition-max testing.
Measured: Baseline and Post-intervention(Week 4)
Changes in Physical Activity Levels
Measured via ActivPal Monitor
Measured: Baseline and Post-intervention(Week 4)
Changes in Food-Related Behaviors
Evaluated via the Food Craving Inventory
Measured: Baseline and Post-intervention(Week 4)
Changes in Food-Related Behaviors
Evaluated via Three-Factor Eating Questionnaire
Measured: Baseline and Post-intervention(Week 4)
Changes in Food-Related Behaviors
Evaluated via the Weight Efficacy Lifestyle Questionnaire
Measured: 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)
Measured: 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)
Measured: Baseline and Post-intervention(Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start12 Jun 2019
- Primary completion3 Sep 2021
- Study completion28 Sep 2022
Why it stopped: Lack of institutional resources to conduct project, increased cost of conducting project due to workarounds with resources not being available, and COVID-19 pausing human subjects data collection in 2020.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants are randomly assigned to one of the two intervention groups.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Halliday, University of Utah
- Investigators
- Tanya M Halliday, PhD, RD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910763
- Sponsor's protocol ID
- 000116248
- Acronym
- PEAR
- Status last verified
- Oct 2022
- First submitted
- 19 Apr 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations to Appetite Regulation Indices in Adults With Prediabetes Following Short-Term Aerobic vs. Resistance Exercise Training
- ClinicalTrials.gov ID
- NCT04910763
- Acronym / sponsor ID
- PEAR / 000116248
- Conditions
- PreDiabetes, Appetitive Behavior
- Keywords
- Resistance Exercise, Pre Diabetes, Appetite
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of institutional resources to conduct project, increased cost of conducting project due to workarounds with resources not being available, and COVID-19 pausing human subjects data collection in 2020.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants are randomly assigned to one of the two intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise | Experimental | Behavioral: Resistance ExerciseResistance 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (16 listed)
- Unstable Cardiovascular Disease
- Uncontrolled hypertension
- Severe hypertriglyceridemia
- History of or active liver disease
- Uncontrolled thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance ExerciseIncreasing strength and fitness and thereby influencing hormones and perceptions involved in appetite regulation. | Behavioural | Resistance Exercise |
Primary outcome
Changes in Appetite Rating
Time frame: 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
Time frame: 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.
8 secondary outcomes
Changes in Body Composition
Time frame: Baseline and Post-intervention(Week 4)
Changes in Maximal Strength
Time frame: Baseline and Post-intervention(Week 4)
Changes in Physical Activity Levels
Time frame: Baseline and Post-intervention(Week 4)
Changes in Food-Related Behaviors
Time frame: Baseline and Post-intervention(Week 4)
Changes in Food-Related Behaviors
Time frame: Baseline and Post-intervention(Week 4)
Changes in Food-Related Behaviors
Time frame: Baseline and Post-intervention(Week 4)
Change in Ad libitum Energy Intake - In lab
Time frame: Baseline and Post-intervention(Week 4)
Changes in Ad libitum Energy Intake - Free Living
Time frame: Baseline and Post-intervention(Week 4)
Results and safety
The study was stopped early (reason given: Lack of institutional resources to conduct project, increased cost of conducting project due to workarounds with resources not being available, and COVID-19 pausing human subjects data collection in 2020.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya M Halliday, PhD, RD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise in people with PreDiabetes and Appetitive Behavior, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of institutional resources to conduct project, increased cost of conducting project due to workarounds with resources not being available, and COVID-19 pausing human subjects data collection in 2020.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Appetite Rating (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.