ObesityNCT02094183
The Interaction Between Appetite Hormones
A study testing GLP-1 and low calorie diet in people with Obesity, run by University of Copenhagen at 2 sites in Denmark.
Trial summary
Glucagon Like Peptide (GLP) -1 affects metabolic response corrected for weight change Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- GLP-1 and low calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2011to Apr 2014
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI > 30 and < 40 (kg/m2)
- Healthy
Who cannot join
- Other known illness
- Medicine that affects glucose- and lipid metabolism, appetite or food intake
- Pregnancy
- Breast feeding
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
University of Copenhagen
Copenhagen, 2200
Hvidovre University Hospital
Hvidovre, 2650
About this study
Official title: The Interaction Between Appetite Hormones and Their Importance for Maintenance of Weight Loss After a Low Calorie Diet
Glucagon Like Peptide (GLP) -1 affects metabolic response corrected for weight change
Read the detailed description
Many obese people have had several successful weight losses, however very few can maintain the weight loss over a longer period (e.g. one year) Therefore, we want to investigate the metabolic response and the importance for maintenance of weight loss in obese people, who lost at least 7, 5 % body weight by low calorie diet followed by 52 weeks of diet weight maintenance with or without supplement of GLP-1.
- Conditions
- Obesity
- Being tested
- GLP-1, low calorie diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Other
GLP-1
low calorie dietDietary supplement
low calorie diet
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 | Experimental | GLP-1 and low calorie diet Receives: Other: GLP-1; Dietary Supplement: low calorie diet |
| Control | Experimental | low calorie diet Receives: Dietary Supplement: low calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hormone level corrected for weight change
Measured: Baseline and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startSep 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council
- Responsible party
- Principal investigator, Signe Torekov, University of Copenhagen
- Investigators
- Jens Holst, DMSCi, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094183
- Sponsor's protocol ID
- H-4-2010-134
- Status last verified
- Jul 2014
- First submitted
- 17 Mar 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brethvad AO, Zakariassen HL, Holt J, Lundgren JR, Jakobsen A, Hartmann B, Lehmann EW, Kissow H, Holst JJ, Madsbad S, Torekov SS, Holst B. Increased meal-induced neurotensin response predicts successful maintenance of weight loss - Data from a randomized controlled trial. Metabolism. 2023 Jun;143:155534. doi: 10.1016/j.metabol.2023.155534. Epub 2023 Mar 16.
PubMed 36933790Akawi N, Checa A, Antonopoulos AS, Akoumianakis I, Daskalaki E, Kotanidis CP, Kondo H, Lee K, Yesilyurt D, Badi I, Polkinghorne M, Akbar N, Lundgren J, Chuaiphichai S, Choudhury R, Neubauer S, Channon KM, Torekov SS, Wheelock CE, Antoniades C. Fat-Secreted Ceramides Regulate Vascular Redox State and Influence Outcomes in Patients With Cardiovascular Disease. J Am Coll Cardiol. 2021 May 25;77(20):2494-2513. doi: 10.1016/j.jacc.2021.03.314.
PubMed 34016263Iepsen EW, Lundgren JR, Hartmann B, Pedersen O, Hansen T, Jorgensen NR, Jensen JE, Holst JJ, Madsbad S, Torekov SS. GLP-1 Receptor Agonist Treatment Increases Bone Formation and Prevents Bone Loss in Weight-Reduced Obese Women. J Clin Endocrinol Metab. 2015 Aug;100(8):2909-17. doi: 10.1210/jc.2015-1176. Epub 2015 Jun 4.
PubMed 26043228
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction Between Appetite Hormones and Their Importance for Maintenance of Weight Loss After a Low Calorie Diet
- ClinicalTrials.gov ID
- NCT02094183
- Acronym / sponsor ID
- H-4-2010-134
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council
- Study start
- Sep 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Mar 2014 (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.
Glucagon Like Peptide (GLP) -1 affects metabolic response corrected for weight change
Detailed description
Many obese people have had several successful weight losses, however very few can maintain the weight loss over a longer period (e.g. one year) Therefore, we want to investigate the metabolic response and the importance for maintenance of weight loss in obese people, who lost at least 7, 5 % body weight by low calorie diet followed by 52 weeks of diet weight maintenance with or without supplement of GLP-1.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 | Experimental | Other: GLP-1, Dietary Supplement: low calorie dietGLP-1 and low calorie diet |
| Control | Experimental | Dietary Supplement: low calorie dietlow calorie diet |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI > 30 and < 40 (kg/m2)
- Healthy
Key exclusion criteria (4 listed)
- Other known illness
- Medicine that affects glucose- and lipid metabolism, appetite or food intake
- Pregnancy
- Breast feeding
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 |
|---|---|---|
| GLP-1GLP-1 | Other | GLP-1 |
| low calorie dietlow calorie diet | Dietary supplement | Control, GLP-1 |
Primary outcome
Change in hormone level corrected for weight change
Time frame: Baseline and week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Derived from this study: PubMed 36933790Brethvad AO, Zakariassen HL, Holt J, Lundgren JR, Jakobsen A, Hartmann B, Lehmann EW, Kissow H, Holst JJ, Madsbad S, Torekov SS, Holst B. Increased meal-induced neurotensin response predicts successful maintenance of weight loss - Data from a randomized controlled trial. Metabolism. 2023 Jun;143:155534. doi: 10.1016/j.metabol.2023.155534. Epub 2023 Mar 16.
- Derived from this study: PubMed 34016263Akawi N, Checa A, Antonopoulos AS, Akoumianakis I, Daskalaki E, Kotanidis CP, Kondo H, Lee K, Yesilyurt D, Badi I, Polkinghorne M, Akbar N, Lundgren J, Chuaiphichai S, Choudhury R, Neubauer S, Channon KM, Torekov SS, Wheelock CE, Antoniades C. Fat-Secreted Ceramides Regulate Vascular Redox State and Influence Outcomes in Patients With Cardiovascular Disease. J Am Coll Cardiol. 2021 May 25;77(20):2494-2513. doi: 10.1016/j.jacc.2021.03.314.
- Derived from this study: PubMed 26043228Iepsen EW, Lundgren JR, Hartmann B, Pedersen O, Hansen T, Jorgensen NR, Jensen JE, Holst JJ, Madsbad S, Torekov SS. GLP-1 Receptor Agonist Treatment Increases Bone Formation and Prevents Bone Loss in Weight-Reduced Obese Women. J Clin Endocrinol Metab. 2015 Aug;100(8):2909-17. doi: 10.1210/jc.2015-1176. Epub 2015 Jun 4.
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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.
Jens Holst, DMSCi study chair
University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 and low calorie diet in people with Obesity, run by University of Copenhagen at 2 sites 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 4 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Change in hormone level corrected for weight change (time frame: Baseline and week 52). 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 NCT02094183, which also lists 3 linked publications.
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 8 Jul 2014.