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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Placebo |
|
| lifestyle intervention | Experimental | After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multimodal lifestyle intervention | Behavioral | After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | month -3, month 0, month 12, month 18 |
| Evaluation of leptin during follow up |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Knut Mai, Prof | Charite | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite | Berlin | 12200 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37730732 | Derived | 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. | |
| 35897098 | Derived | Li 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D015430 | Weight Gain |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| placebo | Behavioral | no intervention, only follow up |
|
Measurement of leptin during follow up until the 48 months |
| 48 months |
| Evaluation of catecholamines during follow up | Measurement of catecholamines during follow up until the 48 months | 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 | 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 | month -3, month 0, month 12, month 18 |
| Evaluation of cortisol during follow up | Measurement of cortisol during follow up until the 48 months | 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 | month -3, month 0, month 12, month 18 |
| Evaluation of GLP1 during follow up | Measurement of GLP1 during follow up until the 48 months | 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 | month -3, month 0, month 12, month 18 |
| Evaluation of GIP during follow up | Measurement of GIP during follow up until the 48 months | 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 | 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 | 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 | month -3, month 0, month 12, month 18 |
| Evaluation of insulin during follow up | Measurement of insulin during follow up until the 48 months | 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 | month -3, month 0, month 12, month 18 |
| Evaluation of IGF1 during follow up | Measurement of IGF1 during follow up until the 48 months | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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 | month -3, month 0, month 12, month 18, month 24, month 36, month 48 |
| 35346256 | Derived | Soll 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. |
| 34611132 | Derived | Li 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. |
| 33065163 | Derived | Li 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. |
| 30552109 | Derived | Brachs 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. |
| 30389745 | Derived | Mai 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. |
| 27298729 | Derived | Bau 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. |
| 27173472 | Derived | Brachs 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. |
| 25576647 | Derived | Weygandt 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |