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Type 2 DiabetesNCT01674049

Nutrient Timing Following Resistance Exercise

A study testing Immediate Nutrition, Nutrition 3 hours Post-Bout and Resistance Exercise in people with Type 2 Diabetes, run by George Washington University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the proposed study is to examine the timing of post-exercise feeding on 15 hours post-exercise glycemic control and metabolic flexibility and in overweight and obese young men with a family history of type 2 diabetes. Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
Immediate Nutrition, Nutrition 3 hours Post-Bout and Resistance Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Oct 2010to May 2011
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 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • BMI= 18-30
  • Report at least one first degree relative with family history of type 2 diabetes - Healthy with no self-report of diagnosis of chronic disease

Who cannot join

  • Self-report prior diagnosis of cardiovascular disease, pulmonary disease, adult asthma, dyspnea on exertion, current bronchitis, pneumonia, or tuberculosis, vascular disease, any intercurrent infection, hematologic/oncologic, any metastatic malignancy, anemia (hematocrit <35), thrombocytopenia, neutropenia, hematologic malignancy, bleeding dyscrasias, neurologic disorder, endocrine disorder, chronic renal diseases
  • Any illegal drug use
  • Coumadin, heparin, beta blocker, growth hormone supplementation, or illegal drug use
  • Skeletal-muscular injury in the last 6 months (including severe sprains, broken bones, and tendon or ligament injuries)
  • Alcohol use in excess of 2 drinks per day
  • Smokers

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The George Washington University

    Washington D.C., District of Columbia, 20052

Other trials in United States

About this study

Official title: Nutrient Timing Following Resistance Exercise in Young Overweight and Obese Young Men With a Family History of Diabetes

The purpose of the proposed study is to examine the timing of post-exercise feeding on 15 hours post-exercise glycemic control and metabolic flexibility and in overweight and obese young men with a family history of type 2 diabetes.

Aim 1 - To determine the temporal effects of post-exercise feeding (i.e., immediate post-exercise vs. 3 hours post-exercise) on glycemic control, peripheral insulin sensitivity, and metabolic flexibility (as evaluated by sleep RQ) in this same group of participants. We hypothesize that a 3 hour delay in nutrient ingestion will promote significantly greater improvements in glucose tolerance, metabolic flexibility, and peripheral insulin sensitivity both immediately and several hours post-ingestion.

Read the detailed description

The proposed study is cross-sectional and utilizes a within-subject design to study young men under two different nutrient timing protocols, which are randomly-ordered and spaced at least 2 weeks apart.

  1. Participants will be screened for eligibility via phone or email and scheduled for an initial visit, in order to consent to the study and undergo some basic baseline evaluations. We will rely on participant self-report to verify absence of chronic disease or drug use.
  2. After consenting to the study, fasting blood glucose, height, weight, and air displacement plethysmography (BodPod®) will be conducted in the Clinical Exercise Physiology Laboratory at The George Washington University, in Washington, DC. These measures may occur on the same day as consent or at another scheduled time.
  3. After screening, consenting, and baseline assessments, participants will undergo 2 experimental conditions, which will be randomly-ordered and approximately 2 weeks apart. If possible, both of these experimental visits will be scheduled shortly after the consent form is signed.
  4. A registered dietitian will instruct participants to eat a standardized (35 kcal∙kg body weight-1∙day-1) diet comprising 60% carbohydrate, 20% protein, and 20% fat for 3 days prior to both experimental sessions. This instruction will be administered after the BodPod® assessment is completed.
  5. Participants will report to the USDA Laboratory chamber at 7:30 AM for the experimental sessions. Height, weight blood pressure and heart rate will be measured, then a fasting blood sample (5 cc) will be obtained for determination of basal glucose \& insulin concentrations. A Hidalgo Ambulatory Monitoring Sensor Array Vest (Equivital I: Hidalgo Ltd., Cambridge UK) will be worn by all participants measured in the calorimeter for the entire 48 period. This device measures heart rate (HR), heat flux, core body temperature, posture and physical activity (PA) from a built-in accelerometer.
  6. Then, the sensor portion of the CGMS then will be placed subcutaneously and the CGMS calibrated with whole blood using the Accu-Check Advantage (Roche Diagnostics, Indianapolis, IL) glucometer. Participants will then enter the whole room calorimeter (metabolic chamber) and complete a hunger scale. Hunger will be evaluated 10-20 minutes before the start of each meal and 2 hours after the resistance exercise bout. On the first day, participants eat a standard breakfast provided by the USDA kitchen at approximately 7:45-8:00AM.
  7. Gutierrez or a research assistant will take obtain glucometer readings before and 60 minutes after each meal to calibrate the the CGMS. These evaluations will occur 4-6 times over the course of the day.
  8. Standardized meals (lunch at 11:00AM and dinner at 7:00PM) will be provided for subjects by the USDA. Blood samples (5 cc each) will be collected prior to and 120 minutes after breakfast and lunch; and prior to and 30-, 60-, 90-, and 120-min following the start of the evening meal for the determination of post-meal responses in glucose \& insulin. A trained phlebotomist with at least 50 successful IV catheter placements will place an IV catheter into the participant's median antecubital vein before the evening meal to facilitate multiple draws after the meal.
  9. On the second day, subjects will awake in the calorimeter at approximately 7:00 AM and a fasting blood sample (5 cc) will be obtained for determination of basal concentrations of glucose \& insulin.
  10. At about 7:30 AM, subjects will eat a standardized breakfast to be consumed by 8:00 AM. Two hours after a standardized lunch meal, served at 11:00AM, participants will perform one of the following resistance exercise nutrient-timing protocols: immediate post-exercise nutrition at approximately 2:00 PM 3 hour post exercise nutrition at approximately 5:00 PM). All participants will undergo both experimental conditions at different testing sessions.
Conditions
Type 2 Diabetes
Being tested
Immediate Nutrition, Nutrition 3 hours Post-Bout, Resistance Exercise
Keywords
nutrition, nutrient, timing, diabetes, family history, dairy
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate NutritionDietary supplement

    Nutritional supplement consumed either immediately following a 40min resistance exercise bout

  • Nutrition 3 hours Post-BoutDietary supplement

    Nutritional supplement (600g low-fat chocolate milk) consumed three hours after the exercise bout

  • Resistance ExerciseOther

    A single 40 minute circuit-style bout of resistance exercise

Study groups in NCT01674049
Study groupRoleWhat they receive
Exercise and Immediate NutritionExperimental40 min of circuit-style resistance exercise and 600g low-fat chocolate milk immediately after the exercise bout
Receives: Dietary Supplement: Immediate Nutrition; Other: Resistance Exercise
Exercise and Nutrition 3 hours Post-BoutActive comparator40 min of circuit-style resistance exercise and 600g low-fat chocolate milk three hours after the exercise bout
Receives: Dietary Supplement: Nutrition 3 hours Post-Bout; Other: Resistance Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Glucose

    Continuous Glucose Monitoring was used for about 48 hours, from the time the participants entered the chamber on the control day through their release two days later

    Measured: 48 hours

Secondary outcomes (1)
  1. Serum insulin

    Measured: 2 hours post supplement ingestion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2012 (estimated)
  2. Study startOct 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01674049
Sponsor's protocol ID
081025
Status last verified
Aug 2012
First submitted
24 Aug 2012
Last updated
29 Aug 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Immediate Nutrition, Nutrition 3 hours Post-Bout and Resistance Exercise in people with Type 2 Diabetes, run by George Washington University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 29 Aug 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Blood Glucose (time frame: 48 hours). 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 29 Aug 2012.

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