ObesityPhase 3GH&LASGBNCT00553852
Replacement GH Therapy After Bariatric Surgery in Patients With Very Severe Obesity
A Phase 3 study testing Recombinant GH Saizen (Merck-Serono) in people with Obesity and GHD, run by Federico II University at 1 site in Italy.
Trial summary
Obesity and obesity-related diseases have reached epidemic proportions in Western countries (1-3). Laparoscopic-adjustable silicone gastric banding (LASGB) is a purely restrictive operation that determine effective weight loss without inducing malabsorption (4-6). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- What is being tested?
- Recombinant GH Saizen (Merck-Serono)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2007to Mar 2008
- Phase
- Phase 3
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-50 yrs
- Normal glucose tolerance during standard oral glucose tolerance test (OGTT)
- Inclusion criteria for bariatric surgery proposed by the 1991 National Institutes of Health Consensus Development Panel Report.
Who cannot join
- Liver or renal failure, cancer, acute or chronic inflammatory diseases
- Chronic treatment with any type of medications
- organic pituitary deficiency
- Bulimia Nervosa of the DSM-IV
- Ulcers or malignancies excluded by oesophagus-gastro-duodenoscopy.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Molecular and Clinical Endocrinology and Oncology Federico II University
Naples, 80131
About this study
Official title: Evaluation of GH/IGF-I Axis and of Replacement GH Therapy After Bariatric Surgery in Patients With Very Severe Obesity: Relationships With Body Composition
Obesity and obesity-related diseases have reached epidemic proportions in Western countries (1-3). Laparoscopic-adjustable silicone gastric banding (LASGB) is a purely restrictive operation that determine effective weight loss without inducing malabsorption (4-6). However, also after LASGB body weight loss is almost invariably associated with Free Fat Mass (FFM) loss, and the relevance of the FFM contribution to total energy expenditure is well-known (7-8). Different endocrine axes are reported to affect FFM. We previously reported that low levels of DHEA-S, an adrenal steroid with controversial anti-adipogenic and anti-atherogenic effects, are increased after the massive and sustainable weight loss induced by LASGB in severely obese premenopausal women and correlated with the higher post-operative FFM (9-10). It is also well known that GH/IGF-I axis exerts relevant effects on FFM and that reduced GH levels might increase Fat Mass (FM) and reduce FFM (11,12). Morbidly obese patients have a reduced GH secretion, generally reversible after weight loss (13-14). In a recent study currently in press, we reported that a persistent deficiency in the GH/IGF-I axis in very obese females is associated to lower decrease in FM after LASGB. Low IGF-I plasma levels have also been reported to be independent prognostic factors of liver steatosis and non-alcoholic steatohepatitis in morbidly obese patients (15) and ultrasound- measured hepatic left lobe volume might represent a reliable tool for the evaluation of liver involvement in obesity (16). GH deficiency (GHD) in adult patients is associated with an increase in FM and a parallel decrease in FFM (17). The severity of GDH is correlated to cardiovascular risk, body composition abnormalities and bone loss, and decreased left ventricular ejection fraction (18-20). GH therapy has been demonstrated to be effective in normalizing body composition, with beneficial effects up to a 2-years follow-up period (21-24). GH therapy has also been reported to be effective in sparing FFM during weight loss in obese patients and metabolic syndrome (25,26). However, these studies have some limitations due to the duration of the treatment and the lack of a preliminary evaluation of the GH/IGF-I axis secretory status in obese patients before the GH therapy. At present there are no data on the evaluation of the GH/IGF-I status before and after bariatric surgery and the effectiveness of recombinant GH treatment in very severe obese patients.
Read the detailed description
The objectives of the study are:
- To evaluate the GH/GF-I status is correlation with body composition in very severe obese patients. IGF-I levels were classified as deficient when the standard deviation score from the mean was <-2 for age and gender.
- To evaluate the efficacy of a medical treatment with recombinant GH replacement therapy in very severe obese patients after LASGB on the Fat mass (%), free fat mass (%), percent decrease of fat mass. In line with GHD diagnosis, obese patients with persistent GHD after bariatric surgery will be randomized to be treated with or without recombinant GH therapy with replacement doses, in addition to the controlled trial of dietary management, as routinely performed after LASGB.
Study protocol The study protocol includes two different arms: a correlation observational longitudinal open study (Phase I), and a treatment study (Phase II).
PHASE I: In the correlation study a clinical, biochemical and instrumental evaluation will be performed in 20-30 patients with very severe obesity (grade III) with GHD followed-up in a multi-disciplinary approach at the Unit of Endocrinology of the Departments of Molecular and Clinical Endocrinology and Oncology and at the Physiology Nutrition Unit of the Department of Neuroscience and the Department of Surgery of "S. Giovanni Bosco" Hospital of Naples, according to the current criteria of the National Institute of Health (27). The clinical examination will focus on the GH/IGF-I status effects on body composition changes before and after LASGB. The clinical examination will determine anthropometric indexes (weight, height, BMI, waist circumference). The biochemical evaluation will include the measurement of lipid profile, fasting plasma glucose and insulin, liver test function, FT3, FT4, GHRH + Arginine test to detect GHD, plasma IGF-I levels. The instrumental evaluation will include DEXA Total Body and bioimpedance analysis to determine body composition, and liver ultrasounds.
PHASE II: In the medical treatment protocol very severe obese patients with persistent GHD after LASGB will be inclosed. Starting from 15-day, GHD patients were re-evaluated by GHRH + Arginine test. After evaluation, the patients with persistent GHD will be randomized to be treated with Recombinant GH replacement therapy (Group A: Recombinant GH replacement therapy at the initial dose 0.15-0.30 mg/die; dose adjustment will be made according to IGF-I levels; Group B: no GH treatment). In both subgroups, the diet will arranged to fit an energy intake of 5.7 MJ/day (55% carbohydrate, 25% fat, 20% protein, 30 g fiber) and a moderate-intensity activity (brisk walking for 30-45 min/day) will be encouraged.
The evaluation of medical treatment efficacy will be based on the analysis of changes in anthropometric indexes, IGF-I levels, liver function test, body composition assessed by DEXA Total Body and bioimpedance analysis, liver ultrasounds. At 3 and 6 months, the patients of both subgroups A and B will be clinically re-evaluated, plasma samples for metabolic, liver function tests, and endocrine profile will be obtained, body composition and liver ultrasounds will be determined. At the end of the 6-months period of treatment and observation, the GH response to a subsequent GHRH + Arginine will be re-tested to confirm or to exclude GHD. All the patients with persistent GHD will continue recombinant GH therapy.
- Being tested
- Recombinant GH Saizen (Merck-Serono)
- Keywords
- Very Severe Obesity, Body Composition, GH deficiency, IGF-I, LASGB, GH therapy
- Medical subject headings
- Obesity, Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant GH Saizen (Merck-Serono)Drug
Treatment will start at the initial dose 0.15-0.30 mg/day; dose adjustment will be performed according to IGF-I levels. The duration of medical treatment is 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The clinical examination will determine anthropometric indexes (weight, height, BMI, waist circumference). The biochemical evaluation will include the measurement of lipid profile, fasting plasma glucose and insulin, liver test function, FT3, FT4, GHRH + Arginine test to detect GHD, plasma IGF-I levels. The instrumental evaluation will include DEXA Total Body and bioimpedance analysis to determine body composition, and liver ultrasounds. Receives: Drug: Recombinant GH Saizen (Merck-Serono) |
| 2 | Placebo comparator | PHASE II: In the medical treatment protocol very severe obese patients with persistent GHD after LASGB will be inclosed. Starting from 15-day, GHD patients were re-evaluated by GHRH + Arginine test. After evaluation, the patients with persistent GHD will be randomized to be treated with Recombinant GH replacement therapy (Group A: Recombinant GH replacement therapy at the initial dose 0.15-0.30 mg/die; dose adjustment will be made according to IGF-I levels; Group B: no GH treatment). Receives: Drug: Recombinant GH Saizen (Merck-Serono) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass (%), free fat mass (%), percent decrease of fat mass.
Measured: 6 months
Secondary outcomes (2)
Lipid profile
Measured: 6 months
Fasting plasma glucose and insulin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Investigators
- Annamaria Colao, MD, PhD, Principal investigator, Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553852
- Sponsor's protocol ID
- NeuroendoUnit-5
- Acronym
- GH&LASGB
- Status last verified
- Mar 2008
- First submitted
- 31 Oct 2007
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Groves T. Pandemic obesity in Europe. BMJ. 2006 Nov 25;333(7578):1081. doi: 10.1136/bmj.39038.449769.BE. Epub 2006 Nov 17.
PubMed 17114210Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
PubMed 15364185Renehan AG, Frystyk J, Flyvbjerg A. Obesity and cancer risk: the role of the insulin-IGF axis. Trends Endocrinol Metab. 2006 Oct;17(8):328-36. doi: 10.1016/j.tem.2006.08.006. Epub 2006 Sep 7.
PubMed 16956771DeMaria EJ. Bariatric surgery for morbid obesity. N Engl J Med. 2007 May 24;356(21):2176-83. doi: 10.1056/NEJMct067019. No abstract available.
PubMed 17522401Kuzmak LI. A Review of Seven Years' Experience with Silicone Gastric Banding. Obes Surg. 1991 Dec;1(4):403-408. doi: 10.1381/096089291765560809.
PubMed 10775942Angrisani L, Lorenzo M, Esposito G, Romano G, Puzziello A, Belfiore A, Santoro T, Roina G, Petito A, Falconi C, Tesauro B. Laparoscopic adjustable silicone gastric banding: preliminary results of the University of Naples experience. Obes Surg. 1997 Feb;7(1):19-21. doi: 10.1381/096089297765556178.
PubMed 9730532Ravussin E, Burnand B, Schutz Y, Jequier E. Energy expenditure before and during energy restriction in obese patients. Am J Clin Nutr. 1985 Apr;41(4):753-9. doi: 10.1093/ajcn/41.4.753.
PubMed 3984927Sergi G, Lupoli L, Busetto L, Volpato S, Coin A, Bertani R, Calliari I, Berton A, Enzi G. Changes in fluid compartments and body composition in obese women after weight loss induced by gastric banding. Ann Nutr Metab. 2003;47(3-4):152-7. doi: 10.1159/000070038.
PubMed 12743467Savastano S, Valentino R, Belfiore A, De Luca N, de Alteriis A, Orio F Jr, Palomba S, Villani AM, Falconi C, Lupoli G, Lombardi G. Early carotid atherosclerosis in normotensive severe obese premenopausal women with low DHEA(S). J Endocrinol Invest. 2003 Mar;26(3):236-43. doi: 10.1007/BF03345163.
PubMed 12809174Savastano S, Belfiore A, Guida B, Angrisani L, Orio F Jr, Cascella T, Milone F, Micanti F, Saldalamacchia G, Lombardi G, Colao A. Role of dehydroepiandrosterone sulfate levels on body composition after laparoscopic adjustable gastric banding in pre-menopausal morbidly obese women. J Endocrinol Invest. 2005 Jun;28(6):509-15. doi: 10.1007/BF03347238.
PubMed 16117191Richelsen B, Pedersen SB, Kristensen K, Borglum JD, Norrelund H, Christiansen JS, Jorgensen JO. Regulation of lipoprotein lipase and hormone-sensitive lipase activity and gene expression in adipose and muscle tissue by growth hormone treatment during weight loss in obese patients. Metabolism. 2000 Jul;49(7):906-11. doi: 10.1053/meta.2000.6738.
PubMed 10910003Umpleby AM, Russell-Jones DL. The hormonal control of protein metabolism. Baillieres Clin Endocrinol Metab. 1996 Oct;10(4):551-70. doi: 10.1016/s0950-351x(96)80711-7.
PubMed 9022951Maccario M, Grottoli S, Procopio M, Oleandri SE, Rossetto R, Gauna C, Arvat E, Ghigo E. The GH/IGF-I axis in obesity: influence of neuro-endocrine and metabolic factors. Int J Obes Relat Metab Disord. 2000 Jun;24 Suppl 2:S96-9. doi: 10.1038/sj.ijo.0801289.
PubMed 10997620Garcia-Galiano D, Sanchez-Garrido MA, Espejo I, Montero JL, Costan G, Marchal T, Membrives A, Gallardo-Valverde JM, Munoz-Castaneda JR, Arevalo E, De la Mata M, Muntane J. IL-6 and IGF-1 are independent prognostic factors of liver steatosis and non-alcoholic steatohepatitis in morbidly obese patients. Obes Surg. 2007 Apr;17(4):493-503. doi: 10.1007/s11695-007-9087-1.
PubMed 17608262Santini F, Giannetti M, Mazzeo S, Fierabracci P, Scartabelli G, Marsili A, Valeriano R, Pucci A, Anselmino M, Zampa V, Vitti P, Pinchera A. Ultrasonographic evaluation of liver volume and the metabolic syndrome in obese women. J Endocrinol Invest. 2007 Feb;30(2):104-10. doi: 10.1007/BF03347407.
PubMed 17392599
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of GH/IGF-I Axis and of Replacement GH Therapy After Bariatric Surgery in Patients With Very Severe Obesity: Relationships With Body Composition
- ClinicalTrials.gov ID
- NCT00553852
- Acronym / sponsor ID
- GH&LASGB / NeuroendoUnit-5
- Keywords
- Very Severe Obesity, Body Composition, GH deficiency, IGF-I, LASGB, GH therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Nov 2007 (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.
Obesity and obesity-related diseases have reached epidemic proportions in Western countries (1-3). Laparoscopic-adjustable silicone gastric banding (LASGB) is a purely restrictive operation that determine effective weight loss without inducing malabsorption (4-6). However, also after LASGB body weight loss is almost invariably associated with Free Fat Mass (FFM) loss, and the relevance of the FFM contribution to total energy expenditure is well-known (7-8). Different endocrine axes are reported to affect FFM. We previously reported that low levels of DHEA-S, an adrenal steroid with controversial anti-adipogenic and anti-atherogenic effects, are increased after the massive and sustainable weight loss induced by LASGB in severely obese premenopausal women and correlated with the higher post-operative FFM (9-10). It is also well known that GH/IGF-I axis exerts relevant effects on FFM and that reduced GH levels might increase Fat Mass (FM) and reduce FFM (11,12). Morbidly obese patients have a reduced GH secretion, generally reversible after weight loss (13-14). In a recent study currently in press, we reported that a persistent deficiency in the GH/IGF-I axis in very obese females is associated to lower decrease in FM after LASGB. Low IGF-I plasma levels have also been reported to be independent prognostic factors of liver steatosis and non-alcoholic steatohepatitis in morbidly obese patients (15) and ultrasound- measured hepatic left lobe volume might represent a reliable tool for the evaluation of liver involvement in obesity (16). GH deficiency (GHD) in adult patients is associated with an increase in FM and a parallel decrease in FFM (17). The severity of GDH is correlated to cardiovascular risk, body composition abnormalities and bone loss, and decreased left ventricular ejection fraction (18-20). GH therapy has been demonstrated to be effective in normalizing body composition, with beneficial effects up to a 2-years follow-up period (21-24). GH therapy has also been reported to be effective in sparing FFM during weight loss in obese patients and metabolic syndrome (25,26). However, these studies have some limitations due to the duration of the treatment and the lack of a preliminary evaluation of the GH/IGF-I axis secretory status in obese patients before the GH therapy. At present there are no data on the evaluation of the GH/IGF-I status before and after bariatric surgery and the effectiveness of recombinant GH treatment in very severe obese patients.
Detailed description
The objectives of the study are:
- To evaluate the GH/GF-I status is correlation with body composition in very severe obese patients. IGF-I levels were classified as deficient when the standard deviation score from the mean was <-2 for age and gender.
- To evaluate the efficacy of a medical treatment with recombinant GH replacement therapy in very severe obese patients after LASGB on the Fat mass (%), free fat mass (%), percent decrease of fat mass. In line with GHD diagnosis, obese patients with persistent GHD after bariatric surgery will be randomized to be treated with or without recombinant GH therapy with replacement doses, in addition to the controlled trial of dietary management, as routinely performed after LASGB.
Study protocol The study protocol includes two different arms: a correlation observational longitudinal open study (Phase I), and a treatment study (Phase II).
PHASE I: In the correlation study a clinical, biochemical and instrumental evaluation will be performed in 20-30 patients with very severe obesity (grade III) with GHD followed-up in a multi-disciplinary approach at the Unit of Endocrinology of the Departments of Molecular and Clinical Endocrinology and Oncology and at the Physiology Nutrition Unit of the Department of Neuroscience and the Department of Surgery of "S. Giovanni Bosco" Hospital of Naples, according to the current criteria of the National Institute of Health (27). The clinical examination will focus on the GH/IGF-I status effects on body composition changes before and after LASGB. The clinical examination will determine anthropometric indexes (weight, height, BMI, waist circumference). The biochemical evaluation will include the measurement of lipid profile, fasting plasma glucose and insulin, liver test function, FT3, FT4, GHRH + Arginine test to detect GHD, plasma IGF-I levels. The instrumental evaluation will include DEXA Total Body and bioimpedance analysis to determine body composition, and liver ultrasounds.
PHASE II: In the medical treatment protocol very severe obese patients with persistent GHD after LASGB will be inclosed. Starting from 15-day, GHD patients were re-evaluated by GHRH + Arginine test. After evaluation, the patients with persistent GHD will be randomized to be treated with Recombinant GH replacement therapy (Group A: Recombinant GH replacement therapy at the initial dose 0.15-0.30 mg/die; dose adjustment will be made according to IGF-I levels; Group B: no GH treatment). In both subgroups, the diet will arranged to fit an energy intake of 5.7 MJ/day (55% carbohydrate, 25% fat, 20% protein, 30 g fiber) and a moderate-intensity activity (brisk walking for 30-45 min/day) will be encouraged.
The evaluation of medical treatment efficacy will be based on the analysis of changes in anthropometric indexes, IGF-I levels, liver function test, body composition assessed by DEXA Total Body and bioimpedance analysis, liver ultrasounds. At 3 and 6 months, the patients of both subgroups A and B will be clinically re-evaluated, plasma samples for metabolic, liver function tests, and endocrine profile will be obtained, body composition and liver ultrasounds will be determined. At the end of the 6-months period of treatment and observation, the GH response to a subsequent GHRH + Arginine will be re-tested to confirm or to exclude GHD. All the patients with persistent GHD will continue recombinant GH therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Recombinant GH Saizen (Merck-Serono)The clinical examination will determine anthropometric indexes (weight, height, BMI, waist circumference). The biochemical evaluation will include the measurement of lipid profile, fasting plasma glucose and insulin, liver test function, FT3, FT4, GHRH + Arginine test to detect GHD, plasma IGF-I levels. The instrumental evaluation will include DEXA Total Body and bioimpedance analysis to determine body composition, and liver ultrasounds. |
| 2 | Placebo comparator | Drug: Recombinant GH Saizen (Merck-Serono)PHASE II: In the medical treatment protocol very severe obese patients with persistent GHD after LASGB will be inclosed. Starting from 15-day, GHD patients were re-evaluated by GHRH + Arginine test. After evaluation, the patients with persistent GHD will be randomized to be treated with Recombinant GH replacement therapy (Group A: Recombinant GH replacement therapy at the initial dose 0.15-0.30 mg/die; dose adjustment will be made according to IGF-I levels; Group B: no GH treatment). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-50 yrs
- Normal glucose tolerance during standard oral glucose tolerance test (OGTT)
- Inclusion criteria for bariatric surgery proposed by the 1991 National Institutes of Health Consensus Development Panel Report.
Key exclusion criteria (5 listed)
- Liver or renal failure, cancer, acute or chronic inflammatory diseases
- Chronic treatment with any type of medications
- organic pituitary deficiency
- Bulimia Nervosa of the DSM-IV
- Ulcers or malignancies excluded by oesophagus-gastro-duodenoscopy.
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 |
|---|---|---|
| Recombinant GH Saizen (Merck-Serono)Treatment will start at the initial dose 0.15-0.30 mg/day; dose adjustment will be performed according to IGF-I levels. The duration of medical treatment is 6 months. | Drug | 1, 2 |
Primary outcome
Fat mass (%), free fat mass (%), percent decrease of fat mass.
Time frame: 6 months
2 secondary outcomes
Lipid profile
Time frame: 6 months
Fasting plasma glucose and insulin
Time frame: 6 months
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 28 Mar 2008.
- Background: PubMed 17114210Groves T. Pandemic obesity in Europe. BMJ. 2006 Nov 25;333(7578):1081. doi: 10.1136/bmj.39038.449769.BE. Epub 2006 Nov 17.
- Background: PubMed 15364185Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
- Background: PubMed 16956771Renehan AG, Frystyk J, Flyvbjerg A. Obesity and cancer risk: the role of the insulin-IGF axis. Trends Endocrinol Metab. 2006 Oct;17(8):328-36. doi: 10.1016/j.tem.2006.08.006. Epub 2006 Sep 7.
- Background: PubMed 17522401DeMaria EJ. Bariatric surgery for morbid obesity. N Engl J Med. 2007 May 24;356(21):2176-83. doi: 10.1056/NEJMct067019. No abstract available.
- Background: PubMed 10775942Kuzmak LI. A Review of Seven Years' Experience with Silicone Gastric Banding. Obes Surg. 1991 Dec;1(4):403-408. doi: 10.1381/096089291765560809.
- Background: PubMed 9730532Angrisani L, Lorenzo M, Esposito G, Romano G, Puzziello A, Belfiore A, Santoro T, Roina G, Petito A, Falconi C, Tesauro B. Laparoscopic adjustable silicone gastric banding: preliminary results of the University of Naples experience. Obes Surg. 1997 Feb;7(1):19-21. doi: 10.1381/096089297765556178.
- Background: PubMed 3984927Ravussin E, Burnand B, Schutz Y, Jequier E. Energy expenditure before and during energy restriction in obese patients. Am J Clin Nutr. 1985 Apr;41(4):753-9. doi: 10.1093/ajcn/41.4.753.
- Background: PubMed 12743467Sergi G, Lupoli L, Busetto L, Volpato S, Coin A, Bertani R, Calliari I, Berton A, Enzi G. Changes in fluid compartments and body composition in obese women after weight loss induced by gastric banding. Ann Nutr Metab. 2003;47(3-4):152-7. doi: 10.1159/000070038.
- Background: PubMed 12809174Savastano S, Valentino R, Belfiore A, De Luca N, de Alteriis A, Orio F Jr, Palomba S, Villani AM, Falconi C, Lupoli G, Lombardi G. Early carotid atherosclerosis in normotensive severe obese premenopausal women with low DHEA(S). J Endocrinol Invest. 2003 Mar;26(3):236-43. doi: 10.1007/BF03345163.
- Background: PubMed 16117191Savastano S, Belfiore A, Guida B, Angrisani L, Orio F Jr, Cascella T, Milone F, Micanti F, Saldalamacchia G, Lombardi G, Colao A. Role of dehydroepiandrosterone sulfate levels on body composition after laparoscopic adjustable gastric banding in pre-menopausal morbidly obese women. J Endocrinol Invest. 2005 Jun;28(6):509-15. doi: 10.1007/BF03347238.
- Background: PubMed 10910003Richelsen B, Pedersen SB, Kristensen K, Borglum JD, Norrelund H, Christiansen JS, Jorgensen JO. Regulation of lipoprotein lipase and hormone-sensitive lipase activity and gene expression in adipose and muscle tissue by growth hormone treatment during weight loss in obese patients. Metabolism. 2000 Jul;49(7):906-11. doi: 10.1053/meta.2000.6738.
- Background: PubMed 9022951Umpleby AM, Russell-Jones DL. The hormonal control of protein metabolism. Baillieres Clin Endocrinol Metab. 1996 Oct;10(4):551-70. doi: 10.1016/s0950-351x(96)80711-7.
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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.
Annamaria Colao, MD, PhD principal investigator
Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant GH Saizen (Merck-Serono) in people with Obesity and GHD, run by Federico II University at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 28 Mar 2008. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fat mass (%), free fat mass (%), percent decrease of fat mass. (time frame: 6 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 NCT00553852, which also lists 27 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 28 Mar 2008.