Diabetes Mellitus, Type 2METFLEXNCT03839641

Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber

A study testing High fat meal and Low fat meal in people with Diabetes Mellitus, Type 2, run by Pennington Biomedical Research Center 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 overarching aim of this study: To determine the effect of different meal compositions (high- vs. low-fat) on metabolic flexibility as it relates to meal-stimulated change in respiratory quotient (ΔRQ1) and sleep (ΔRQ2) metabolic flexibility, as well as the time course changes in respiratory quotient, RQ (i.e.… Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: High fat meal and Low fat meal
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 14 Jan 2019to 31 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Eligibility criteria include:
Healthy male or female
Ages 18-40 y
BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
Are willing to consume pre-prepared meals
Are willing to maintain current physical activity, sleep schedule, and dietary habits during the study.
Medically cleared for participation in the study by Medical Investigator

Who cannot join

Participants are ineligible to participate (or will be excluded from participating in this study) if they meet any of the following criteria:
Unstable weight in the last 3 months [gain or loss >7 lb (or 3.2 kg)]
Currently working shift work
Smoking or use of tobacco products within the last 3 months
Amenorrhea (or absence of regular monthly cycles)
History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL

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Average screening blood pressure >140/90 mmHg
Previous bariatric surgery (or other surgeries) for obesity or weight loss
Use of medications affecting metabolism or sleep
History of neurological disease
History of cardiovascular disease (or other chronic diseases)
Pregnant, planning to become pregnant, or breastfeeding
Adherence to special restrained diets (e.g., low-carbohydrate, low-fat, or vegetarian/vegan diets) over the last 3 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124

Other trials in United States

About this study

Conditions: Diabetes Mellitus, Type 2
Being tested: High fat meal, Low fat meal
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

High fat mealOther
60% fat meal
Low fat mealOther
20% fat meal

Study groups in NCT03839641
Study group	Role	What they receive
High Fat Meal First	Experimental	Arm 1 participants randomized to receive high fat meal first, and low fat meal second Receives: Other: High fat meal; Other: Low fat meal
High Fat Meal Second	Experimental	Arm 2 participants randomized to receive low fat meal first, and high fat meal second Receives: Other: High fat meal; Other: Low fat meal

What is being measured

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

Overnight Respiratory Exchange Ratio
12-h mean of respiratory exchange ratio following each meal type.
measurement interval = 12h following start of meal (7pm)
The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.
Measured: 12 hours

Secondary outcomes (6)

Sleep Respiratory Exchange Ratio
mean of respiratory exchange ratio following each meal type during sleep period, 2am-5am., 2am-5am.
measurement interval = 3h (2am-5am)
The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.
Measured: 3 h
Peak Increase in Respiratory Exchange Ratio
mean of peak increase in respiratory exchange ratio (Peak values - baseline values) following each meal type
Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.
Baseline values were measured 1h prior to meal (5:00-5:45pm)
measurement interval of peak values= 4h (6pm-10pm)
A larger value in this measurement indicates that more carbohydrate than fats were being oxidized as fuel during the measurement period.
Measured: 4 h
Peak Decrease in Respiratory Exchange Ratio
mean of peak decrease in respiratory exchange ratio (baseline values -nadir values) following each meal type
Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.
Baseline values were measured 1h prior to meal (5:00-5:45pm)
measurement interval of nadir values= 12h (6pm-6am)
A larger value in this measurement indicates that more fats than carbohydrate were being oxidized as fuel during the measurement period.
Measured: 12 h
Time to Peak Respiratory Exchange Ratio
Average time from meal to peak respiratory exchange ratio value
This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their highest/peak respiratory exchange ratio value.
Measured: 12 h
Time to Nadir Respiratory Exchange Ratio
Average time from meal to nadir respiratory exchange ratio value
This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their lowest/nadir respiratory exchange ratio value.
Measured: 12 h
Slope of Respiratory Exchange Ratio
This value indicates the speed and magnitude of the participants change in respiratory exchange ratio between the peak and nadir values.
A more negative value in this measurement indicates either a short time interval between the highest and lowest respiratory exchange ratio values measured and/or a large difference between the highest and lowest values of respiratory exchange ratio values measured.
Measured: 12 h

Timeline

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

14 Jan 201931 Dec 2020

First posted15 Feb 2019
Study start14 Jan 2019
Primary completion31 Dec 2019
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03839641
Sponsor's protocol ID: PBRC 2018-029
Acronym: METFLEX
Status last verified: Aug 2021
First submitted: 11 Feb 2019
Last updated: 17 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber
ClinicalTrials.gov ID: NCT03839641
Acronym / sponsor ID: METFLEX / PBRC 2018-029
Conditions: Diabetes Mellitus, Type 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Study start: 14 Jan 2019 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 15 Feb 2019 (actual)
Results: Posted 17 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
High Fat Meal First	Experimental	Other: High fat meal, Other: Low fat mealArm 1 participants randomized to receive high fat meal first, and low fat meal second
High Fat Meal Second	Experimental	Other: High fat meal, Other: Low fat mealArm 2 participants randomized to receive low fat meal first, and high fat meal second

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Eligibility criteria include:

Key exclusion criteria (13 listed)

Participants are ineligible to participate (or will be excluded from participating in this study) if they meet any of the following criteria:

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
High fat meal60% fat meal	Other	High Fat Meal First, High Fat Meal Second
Low fat meal20% fat meal	Other	High Fat Meal First, High Fat Meal Second

Primary outcome

Overnight Respiratory Exchange Ratio
Time frame: 12 hours
12-h mean of respiratory exchange ratio following each meal type. measurement interval = 12h following start of meal (7pm) The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.

6 secondary outcomes

Sleep Respiratory Exchange Ratio
Time frame: 3 h
Peak Increase in Respiratory Exchange Ratio
Time frame: 4 h
Peak Decrease in Respiratory Exchange Ratio
Time frame: 12 h
Time to Peak Respiratory Exchange Ratio
Time frame: 12 h
Time to Nadir Respiratory Exchange Ratio
Time frame: 12 h
Slope of Respiratory Exchange Ratio
Time frame: 12 h

Results and safety

Results posted to the registry on 17 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High-fat Meal, Washout (5-7 Days), and Low-fat Meal	5	4
Low-fat Meal, Washout (5-7 Days), and High-fat Meal	5	4

Primary outcome: Overnight Respiratory Exchange Ratio

Time frame: 12 hours. Mean (Standard Deviation). Unit: ratio

Measure	High Fat Meal n = 8	Low-fat Meal n = 8
Value	0.832 (0.014)	0.887 (0.017)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment through study completion, an average of 20 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High-fat Meal	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Low-fat Meal	0 of 8 (0%)	2 of 8 (25%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus, Type 2

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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High fat meal and Low fat meal in people with Diabetes Mellitus, Type 2, run by Pennington Biomedical Research Center 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 7 inclusion and 13 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 17 Sep 2021. 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?

Yes. Results are posted in the registry (first posted 17 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overnight Respiratory Exchange Ratio (time frame: 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03839641.

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 Sep 2021.