Diabetes Mellitus, Type 2NCT02592616
Interval-training and Appetite Regulation in Patients With Type 2 Diabetes
A study testing CON, CW and IW in people with Diabetes Mellitus, Type 2, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Four months of interval walking (IW) training results in substantial weight loss in opposition to energy-expenditure matched continuous walking (CW) training. The reason for this is unclear. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- CON, CW and IW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Oct 2016
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus
- BMI > 25
Who cannot join
- Pregnancy
- Smoking
- Contraindication to increased levels of physical activity
- Eating disorder
- Insulin dependence
Trial locations and contacts
1 site in 1 country.
About this study
Four months of interval walking (IW) training results in substantial weight loss in opposition to energy-expenditure matched continuous walking (CW) training. The reason for this is unclear.
This study will assess if IW leads to greater exercise-induced suppression of appetite and ad libitum food intake compared to CW and no exercise.
Read more
Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:
- One hour of rest (CON)
- One hour of interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW)
- One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.
After the interventions subjects will undergo a liquid mixed meal tolerance test (450 kCal), with regular measurements of appetite-related hormones (insulin, ghrelin, Leptin, Cholecystokinin, PYY). Three hours into the mixed meal tolerance test, a standardised ad-libitum meal test will be served and intake will recorded. Free-living energy intake via food records will be assessed during the following 32 hours.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- CON, CW, IW
- Keywords
- Exercise, Appetite, Energy intake
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONBehavioural
No exercise intervention.
CWBehavioural
One hour of continuous walking on a treadmill.
IWBehavioural
One hour of interval (repeated cycles of 3 minutes of fast and 3 minutes of slow) walking on treadmill.
| Study group | Role | What they receive |
|---|---|---|
| CON | Experimental | Control (CON). Receives: Behavioral: CON |
| CW | Experimental | Continuous Walking (CW). Receives: Behavioral: CW |
| IW | Experimental | Interval Walking (IW). Receives: Behavioral: IW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad-libitum meal energy intake
Subjects will receive a standardized ad-libitum meal and energy intake will be assessed
Measured: Initiated 3 hours after the intervention
Secondary outcomes (3)
Free-living energy intake
Subjects will complete diet records for 32 hours following the ad-libitum meal and energy intake will be assessed.
Measured: For 32 hours following the ad-libitum meal.
Appetite-related hormones
Appetite-related hormones (insulin, ghrelin, leptin, cholecyctokinin, PYY) will be analysed in blood samples collected regularly during the liquid mixed-meal tolerance test following the intervention
Measured: Regularly during the 3 hours following the intervention
Satiety
Satiety questionaires will be completed at regular intervals after the intervention
Measured: Regular assessments for 36 hours following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Rasmussen Rinnov, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592616
- Sponsor's protocol ID
- H-15008542
- Status last verified
- Jun 2016
- First submitted
- 28 Oct 2015
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interval-training and Appetite Regulation in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02592616
- Acronym / sponsor ID
- H-15008542
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Exercise, Appetite, Energy intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- 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.
Four months of interval walking (IW) training results in substantial weight loss in opposition to energy-expenditure matched continuous walking (CW) training. The reason for this is unclear.
This study will assess if IW leads to greater exercise-induced suppression of appetite and ad libitum food intake compared to CW and no exercise.
Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:
- One hour of rest (CON)
- One hour of interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW)
- One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.
After the interventions subjects will undergo a liquid mixed meal tolerance test (450 kCal), with regular measurements of appetite-related hormones (insulin, ghrelin, Leptin, Cholecystokinin, PYY). Three hours into the mixed meal tolerance test, a standardised ad-libitum meal test will be served and intake will recorded. Free-living energy intake via food records will be assessed during the following 32 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CON | Experimental | Behavioral: CONControl (CON). |
| CW | Experimental | Behavioral: CWContinuous Walking (CW). |
| IW | Experimental | Behavioral: IWInterval Walking (IW). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 Diabetes Mellitus
- BMI > 25
Key exclusion criteria (5 listed)
- Pregnancy
- Smoking
- Contraindication to increased levels of physical activity
- Eating disorder
- Insulin dependence
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 |
|---|---|---|
| CONNo exercise intervention. | Behavioural | CON |
| CWOne hour of continuous walking on a treadmill. | Behavioural | CW |
| IWOne hour of interval (repeated cycles of 3 minutes of fast and 3 minutes of slow) walking on treadmill. | Behavioural | IW |
Primary outcome
Ad-libitum meal energy intake
Time frame: Initiated 3 hours after the intervention
Subjects will receive a standardized ad-libitum meal and energy intake will be assessed
3 secondary outcomes
Free-living energy intake
Time frame: For 32 hours following the ad-libitum meal.
Appetite-related hormones
Time frame: Regularly during the 3 hours following the intervention
Satiety
Time frame: Regular assessments for 36 hours following the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
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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 CON, CW and IW in people with Diabetes Mellitus, Type 2, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 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: status not confirmed, as of the sponsor's last update on 22 Jun 2016. 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 Denmark. 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?
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?
Ad-libitum meal energy intake (time frame: Initiated 3 hours after the intervention). 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 22 Jun 2016.