ObesityNCT00850629
Hormonal Regulation of Body Weight Maintenance
A study testing multimodal lifestyle intervention in people with Obesity and Weight Loss, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. Read more about this study
- Who is it for?
- Ages 10 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, Weight Gain
- What is being tested?
- multimodal lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jan 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 10 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- BMI > 27 kg/m2 (adults)
Who cannot join
- weight loss of more than 5kg in the last 2 months
- pregnancy, breastfeeding
- patients with:
- severe heart failure
- impaired hepatic or renal function
- anaemia
Show all 13Show fewer
- disturbed coagulation (biopsies will not be taken in those subjects)
- infection, malabsorption
- severe hypertension
- cancer within the last 5 years
- eating disorders or any other psychiatric condition that would interact with the trial intervention
- any other endocrine disorder
- changes of smoking habits or diets within the last 3 months prior to study inclusion
Trial locations and contacts
1 site in 1 country.
About this study
The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.
- Conditions
- Obesity, Weight Loss, Weight Gain, Hormone Disturbance, Adipose Tissue, Insulin Resistance
- Being tested
- multimodal lifestyle intervention, placebo
- Keywords
- weight regain, endocrine counterregulation
- Medical subject headings
- Obesity, Weight Loss, Weight Gain, Endocrine System Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal lifestyle interventionBehavioural
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
placeboBehavioural
no intervention, only follow up
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Placebo Receives: Behavioral: placebo |
| lifestyle intervention | Experimental | After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults Receives: Behavioral: multimodal lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
BMI (kg/m2) will be analyzed after intentional weight loss in two comparable parts of a randomized controlled trial including (1) children and adolescents and (2) adults. Therefore effects of a multimodal lifestyle intervention will be compared to placebo.
Measured: 21 months
Secondary outcomes (33)
Evaluation of leptin during lifestyle intervention
Measurement of leptin at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Measured: month -3, month 0, month 12, month 18
Evaluation of leptin during follow up
Measurement of leptin during follow up until the 48 months
Measured: 48 months
Evaluation of catecholamines during follow up
Measurement of catecholamines during follow up until the 48 months
Measured: 48 months
Evaluation of catecholamines during lifestyle intervention
Measurement of catecholamines at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Measured: month -3, month 0, month 12, month 18
Evaluation of cortisol during lifestyle intervention
Measurement of cortisol at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Measured: month -3, month 0, month 12, month 18
Evaluation of cortisol during follow up
Measurement of cortisol during follow up until the 48 months
Measured: 48 months
Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention
Measurement of GLP1 at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Measured: month -3, month 0, month 12, month 18
Evaluation of GLP1 during follow up
Measurement of GLP1 during follow up until the 48 months
Measured: 48 months
Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention
Measurement of GIP at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Measured: month -3, month 0, month 12, month 18
Evaluation of GIP during follow up
Measurement of GIP during follow up until the 48 months
Measured: 48 months
Evaluation of thyroid hormones during lifestyle intervention
Measurement of thyroid hormones at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Measured: month -3, month 0, month 12, month 18
Evaluation of thyroid hormones during follow up
Measurement of thyroid hormones during follow up until the 48 months
Measured: 48 months
Evaluation of insulin during lifestyle intervention
Measurement of insulin at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Measured: month -3, month 0, month 12, month 18
Evaluation of insulin during follow up
Measurement of insulin during follow up until the 48 months
Measured: 48 months
Evaluation of insulin-like growth factor 1 (IGF1) during lifestyle intervention
Measurement of IGF1 at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Measured: month -3, month 0, month 12, month 18
Evaluation of IGF1 during follow up
Measurement of IGF1 during follow up until the 48 months
Measured: 48 months
Evaluation of natriuretic peptide during lifestyle intervention
Measurement of natriuretic peptide at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
Measured: month -3, month 0, month 12, month 18
Evaluation of natriuretic peptide during follow up
Measurement of natriuretic peptide during follow up until the 48 months
Measured: 48 months
Evaluation of blood pressure during lifestyle intervention
Measurement of blood pressure at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Measured: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Evaluation of free fatty acids (FFAs) during lifestyle intervention
Measurement of FFAs at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Measured: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Evaluation of respiratory coefficient during lifestyle intervention
Measurement of respiratory coefficient at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Measured: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Measurement of messenger ribonucleic acid (mRNA) changes in adipose and skeletal muscle before (T-3), after weight loss (T0) and after as well as after 12 months randomized lifestyle intervention (or placebo)
Measurement of systemic and tissue specific changes in adipose tissue and skeletal muscle using RNA sequencing (counts)
Measured: month -3, month 0, month 12
Measurement of insulin sensitivity
Measurement of systemic and tissue specific changes in adipose and muscle insulin sensitivity using hyperinsulinemic clamp (mg•kg-1•min-1/(mU•L-1)) before (T-3), after weight loss (T0) and after as well as after 12 months randomized lifestyle intervention (or placebo)
Measured: month -3, month 0, month 12
Prediction of body weight regain
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on long-term course of BMI (18 and 48 months) using mathematical models
Measured: month 18, month 48
Prediction of insulin sensitivity
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on insulin sensitivity (18 and 48 months) using mathematical models
Measured: month 18, month 48
Prediction of energy expenditure
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on energy expenditure (18 and 48 months) using mathematical models
Measured: month 18, month 48
Prediction of muscle mass
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on muscle mass (18 and 48 months) using mathematical models
Measured: month 18, month 48
Prediction of fat mass
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on fat mass (18 and 48 months) using mathematical models
Measured: month 18, month 48
BMI course after a lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
BMI (kg/m2) after the randomized control trial (RCT) (18 months) will be analyzed up to 48 months.
Measured: month 24, month 36, month 48
changes of fatty acids during the intervention
Analysis of fatty acids at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Measured: month -3, month 0, month 12, month 18, month 24, month 36, month 48
changes acylcarnitines
Analysis of acylcarnitines at baseline and after 3 months of weight loss
Measured: month -3, month 0
changes acylcarnitines
Analysis of acylcarnitines after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Measured: month 12, month 18, month 24, month 36, month 48
body composition
Whole body fat mass (kg, %) will be measured at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
Measured: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Professor Joachim Spranger, Charite University, Berlin, Germany
- Investigators
- Knut Mai, Prof, Principal investigator, Charite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850629
- Sponsor's protocol ID
- EA2/017/09
- Status last verified
- Jan 2018
- First submitted
- 17 Feb 2009
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Haberbosch L, Kierszniowska S, Willmitzer L, Mai K, Spranger J, Maurer L. 5-Aminovaleric acid betaine predicts impaired glucose metabolism and diabetes. Nutr Diabetes. 2023 Sep 20;13(1):17. doi: 10.1038/s41387-023-00245-3.
PubMed 37730732Li L, Soll D, Leupelt V, Spranger J, Mai K. Weight loss-induced improvement of body weight and insulin sensitivity is not amplified by a subsequent 12-month weight maintenance intervention but is predicted by adaption of adipose atrial natriuretic peptide system: 48-month results of a randomized controlled trial. BMC Med. 2022 Jul 28;20(1):238. doi: 10.1186/s12916-022-02435-9.
PubMed 35897098Soll D, Gawron J, Pletsch-Borba L, Spranger J, Mai K. Long-term impact of the metabolic status on weight loss-induced health benefits. Nutr Metab (Lond). 2022 Mar 28;19(1):25. doi: 10.1186/s12986-022-00660-w.
PubMed 35346256Li L, Spranger L, Stobaus N, Beer F, Decker AM, Wernicke C, Brachs S, Brachs M, Spranger J, Mai K. Fetuin-B, a potential link of liver-adipose tissue cross talk during diet-induced weight loss-weight maintenance. Nutr Diabetes. 2021 Oct 5;11(1):31. doi: 10.1038/s41387-021-00174-z.
PubMed 34611132Li L, Spranger L, Soll D, Beer F, Brachs M, Spranger J, Mai K. Metabolic impact of weight loss induced reduction of adipose ACE-2 - Potential implication in COVID-19 infections? Metabolism. 2020 Dec;113:154401. doi: 10.1016/j.metabol.2020.154401. Epub 2020 Oct 13.
PubMed 33065163Brachs S, Polack J, Brachs M, Jahn-Hofmann K, Elvert R, Pfenninger A, Barenz F, Margerie D, Mai K, Spranger J, Kannt A. Genetic Nicotinamide N-Methyltransferase (Nnmt) Deficiency in Male Mice Improves Insulin Sensitivity in Diet-Induced Obesity but Does Not Affect Glucose Tolerance. Diabetes. 2019 Mar;68(3):527-542. doi: 10.2337/db18-0780. Epub 2018 Dec 14.
PubMed 30552109Mai K, Li L, Wiegand S, Brachs M, Leupelt V, Ernert A, Kuhnen P, Hubner N, Robinson P, Chen W, Krude H, Spranger J. An Integrated Understanding of the Molecular Mechanisms of How Adipose Tissue Metabolism Affects Long-term Body Weight Maintenance. Diabetes. 2019 Jan;68(1):57-65. doi: 10.2337/db18-0440. Epub 2018 Nov 2.
PubMed 30389745Bau AM, Ernert A, Krude H, Wiegand S. Hormonal regulatory mechanisms in obese children and adolescents after previous weight reduction with a lifestyle intervention: maintain - paediatric part - a RCT from 2009-15. BMC Obes. 2016 Jun 10;3:29. doi: 10.1186/s40608-016-0110-8. eCollection 2016.
PubMed 27298729Brachs M, Wiegand S, Leupelt V, Ernert A, Kintscher U, Jumpertz von Schwarzenberg R, Decker AM, Bobbert T, Hubner N, Chen W, Krude H, Spranger J, Mai K. ANP system activity predicts variability of fat mass reduction and insulin sensitivity during weight loss. Metabolism. 2016 Jun;65(6):935-43. doi: 10.1016/j.metabol.2016.03.013. Epub 2016 Apr 7.
PubMed 27173472Weygandt M, Mai K, Dommes E, Ritter K, Leupelt V, Spranger J, Haynes JD. Impulse control in the dorsolateral prefrontal cortex counteracts post-diet weight regain in obesity. Neuroimage. 2015 Apr 1;109:318-27. doi: 10.1016/j.neuroimage.2014.12.073. Epub 2015 Jan 7.
PubMed 25576647
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Regulation of Body Weight Maintenance
- ClinicalTrials.gov ID
- NCT00850629
- Acronym / sponsor ID
- EA2/017/09
- Conditions
- Obesity, Weight Loss, Weight Gain, Hormone Disturbance, Adipose Tissue, Insulin Resistance
- Keywords
- weight regain, endocrine counterregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Feb 2009 (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.
The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Behavioral: placeboPlacebo |
| lifestyle intervention | Experimental | Behavioral: multimodal lifestyle interventionAfter an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- BMI > 27 kg/m2 (adults)
Key exclusion criteria (13 listed)
- weight loss of more than 5kg in the last 2 months
- pregnancy, breastfeeding
- patients with:
- changes of smoking habits or diets within the last 3 months prior to study inclusion
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 |
|---|---|---|
| multimodal lifestyle interventionAfter an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults | Behavioural | lifestyle intervention |
| placebono intervention, only follow up | Behavioural | placebo |
Primary outcome
BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Time frame: 21 months
BMI (kg/m2) will be analyzed after intentional weight loss in two comparable parts of a randomized controlled trial including (1) children and adolescents and (2) adults. Therefore effects of a multimodal lifestyle intervention will be compared to placebo.
33 secondary outcomes
Evaluation of leptin during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18
Evaluation of leptin during follow up
Time frame: 48 months
Evaluation of catecholamines during follow up
Time frame: 48 months
Evaluation of catecholamines during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18
Evaluation of cortisol during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18
Evaluation of cortisol during follow up
Time frame: 48 months
Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18
Evaluation of GLP1 during follow up
Time frame: 48 months
Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18
Evaluation of GIP during follow up
Time frame: 48 months
Evaluation of thyroid hormones during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18
Evaluation of thyroid hormones during follow up
Time frame: 48 months
Evaluation of insulin during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18
Evaluation of insulin during follow up
Time frame: 48 months
Evaluation of insulin-like growth factor 1 (IGF1) during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18
Evaluation of IGF1 during follow up
Time frame: 48 months
Evaluation of natriuretic peptide during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18
Evaluation of natriuretic peptide during follow up
Time frame: 48 months
Evaluation of blood pressure during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Evaluation of free fatty acids (FFAs) during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Evaluation of respiratory coefficient during lifestyle intervention
Time frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Measurement of messenger ribonucleic acid (mRNA) changes in adipose and skeletal muscle before (T-3), after weight loss (T0) and after as well as after 12 months randomized lifestyle intervention (or placebo)
Time frame: month -3, month 0, month 12
Measurement of insulin sensitivity
Time frame: month -3, month 0, month 12
Prediction of body weight regain
Time frame: month 18, month 48
Prediction of insulin sensitivity
Time frame: month 18, month 48
Prediction of energy expenditure
Time frame: month 18, month 48
Prediction of muscle mass
Time frame: month 18, month 48
Prediction of fat mass
Time frame: month 18, month 48
BMI course after a lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Time frame: month 24, month 36, month 48
changes of fatty acids during the intervention
Time frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
changes acylcarnitines
Time frame: month -3, month 0
changes acylcarnitines
Time frame: month 12, month 18, month 24, month 36, month 48
body composition
Time frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
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 17 Jan 2018.
- Derived from this study: PubMed 37730732Haberbosch L, Kierszniowska S, Willmitzer L, Mai K, Spranger J, Maurer L. 5-Aminovaleric acid betaine predicts impaired glucose metabolism and diabetes. Nutr Diabetes. 2023 Sep 20;13(1):17. doi: 10.1038/s41387-023-00245-3.
- Derived from this study: PubMed 35897098Li L, Soll D, Leupelt V, Spranger J, Mai K. Weight loss-induced improvement of body weight and insulin sensitivity is not amplified by a subsequent 12-month weight maintenance intervention but is predicted by adaption of adipose atrial natriuretic peptide system: 48-month results of a randomized controlled trial. BMC Med. 2022 Jul 28;20(1):238. doi: 10.1186/s12916-022-02435-9.
- Derived from this study: PubMed 35346256Soll D, Gawron J, Pletsch-Borba L, Spranger J, Mai K. Long-term impact of the metabolic status on weight loss-induced health benefits. Nutr Metab (Lond). 2022 Mar 28;19(1):25. doi: 10.1186/s12986-022-00660-w.
- Derived from this study: PubMed 34611132Li L, Spranger L, Stobaus N, Beer F, Decker AM, Wernicke C, Brachs S, Brachs M, Spranger J, Mai K. Fetuin-B, a potential link of liver-adipose tissue cross talk during diet-induced weight loss-weight maintenance. Nutr Diabetes. 2021 Oct 5;11(1):31. doi: 10.1038/s41387-021-00174-z.
- Derived from this study: PubMed 33065163Li L, Spranger L, Soll D, Beer F, Brachs M, Spranger J, Mai K. Metabolic impact of weight loss induced reduction of adipose ACE-2 - Potential implication in COVID-19 infections? Metabolism. 2020 Dec;113:154401. doi: 10.1016/j.metabol.2020.154401. Epub 2020 Oct 13.
- Derived from this study: PubMed 30552109Brachs S, Polack J, Brachs M, Jahn-Hofmann K, Elvert R, Pfenninger A, Barenz F, Margerie D, Mai K, Spranger J, Kannt A. Genetic Nicotinamide N-Methyltransferase (Nnmt) Deficiency in Male Mice Improves Insulin Sensitivity in Diet-Induced Obesity but Does Not Affect Glucose Tolerance. Diabetes. 2019 Mar;68(3):527-542. doi: 10.2337/db18-0780. Epub 2018 Dec 14.
- Derived from this study: PubMed 30389745Mai K, Li L, Wiegand S, Brachs M, Leupelt V, Ernert A, Kuhnen P, Hubner N, Robinson P, Chen W, Krude H, Spranger J. An Integrated Understanding of the Molecular Mechanisms of How Adipose Tissue Metabolism Affects Long-term Body Weight Maintenance. Diabetes. 2019 Jan;68(1):57-65. doi: 10.2337/db18-0440. Epub 2018 Nov 2.
- Derived from this study: PubMed 27298729Bau AM, Ernert A, Krude H, Wiegand S. Hormonal regulatory mechanisms in obese children and adolescents after previous weight reduction with a lifestyle intervention: maintain - paediatric part - a RCT from 2009-15. BMC Obes. 2016 Jun 10;3:29. doi: 10.1186/s40608-016-0110-8. eCollection 2016.
- Derived from this study: PubMed 27173472Brachs M, Wiegand S, Leupelt V, Ernert A, Kintscher U, Jumpertz von Schwarzenberg R, Decker AM, Bobbert T, Hubner N, Chen W, Krude H, Spranger J, Mai K. ANP system activity predicts variability of fat mass reduction and insulin sensitivity during weight loss. Metabolism. 2016 Jun;65(6):935-43. doi: 10.1016/j.metabol.2016.03.013. Epub 2016 Apr 7.
- Derived from this study: PubMed 25576647Weygandt M, Mai K, Dommes E, Ritter K, Leupelt V, Spranger J, Haynes JD. Impulse control in the dorsolateral prefrontal cortex counteracts post-diet weight regain in obesity. Neuroimage. 2015 Apr 1;109:318-27. doi: 10.1016/j.neuroimage.2014.12.073. Epub 2015 Jan 7.
- Individual participant dataSharing planned: No
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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.
Knut Mai, Prof principal investigator
Charite
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal lifestyle intervention in people with Obesity and Weight Loss, run by Charite University, Berlin, Germany at 1 site in Germany.
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 1 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 Jan 2018. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo (time frame: 21 months). 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 NCT00850629, which also lists 10 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 17 Jan 2018.