scholarly journals Orlistat Therapy for Children With Type 1 Hyperlipoproteinemia: A Randomized Clinical Trial

2018 ◽  
Vol 103 (6) ◽  
pp. 2403-2407 ◽  
Author(s):  
Nivedita Patni ◽  
Claudia Quittner ◽  
Abhimanyu Garg
Keyword(s):  
Clinical Trial ◽  
Medical Center ◽  
Therapeutic Option ◽  
Genetic Disorder ◽  
Serum Triglyceride ◽  
Low Fat ◽  
Open Label ◽  
Serum Triglycerides ◽  
Low Fat Diet

Abstract Context Patients with type 1 hyperlipoproteinemia (T1HLP), a rare genetic disorder, have extreme chylomicronemia and recurrent episodes of acute pancreatitis. Currently, the only therapeutic option is to consume an extremely low-fat diet because the triglyceride-lowering medications are not efficacious. Objective To determine the efficacy of orlistat, a gastric and pancreatic lipase inhibitor, in reducing serum triglyceride levels in patients with T1HLP. Design and Setting We conducted a randomized, open-label, clinical trial with a four-period, two-sequence (“orlistat” and “off orlistat” for 3 months), crossover study design. Patients Two unrelated young Asian Indian males (11 and 9 years old) with T1HLP due to homozygous large GPIHBP1 deletions were enrolled at the UT Southwestern Medical Center. The patients were randomized to receive 3 months of orlistat or no therapy (off), then crossed over to the other arm, and this sequence was then repeated. Fasting serum triglyceride levels, fat-soluble vitamins, and gastrointestinal side effects were assessed. Results Compared with the two off periods, orlistat therapy reduced serum triglycerides by 53.3% and 53.0% in patient 1 and 45.8% and 62.2% in patient 2. There was no deficiency of fat-soluble vitamin levels, and their growth continued. There were no serious adverse effects of orlistat; patient 1 had a mild increase in passage of gas and bloating, and patient 2 had constipation with mild stool leakage. Conclusion Orlistat is safe and highly efficacious in lowering serum triglycerides in children with T1HLP and should be the first-line therapy in conjunction with an extremely low-fat diet.

scholarly journals Effect of a low‐fat diet on serum triglyceride and cholesterol concentrations and lipoprotein profiles in Miniature Schnauzers with hypertriglyceridemia

2020 ◽  
Vol 34 (6) ◽  
pp. 2605-2616
Author(s):  
Panagiotis G. Xenoulis ◽  
Paul J. Cammarata ◽  
Rosemary L. Walzem ◽  
Jan S. Suchodolski ◽  
Jörg M. Steiner
Keyword(s):  
Serum Triglyceride ◽  
Low Fat ◽  
Low Fat Diet ◽  
Lipoprotein Profiles

Strategies to Maintain Long Term Adherence to a Very Low Fat Diet in a Large Scale Clinical Trial

1999 ◽  
Vol 99 (9) ◽  
pp. A34
Author(s):  
K. Hoy ◽  
B. Winters ◽  
M. Lubin ◽  
E. Falk ◽  
D. Nixon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Large Scale ◽  
Low Fat ◽  
Low Fat Diet ◽  
Large Scale Clinical Trial

Can a Mediterranean diet reduce the effects of lipodystrophy syndrome in people living with HIV? A pilot randomised controlled trial

Sexual Health ◽  
2011 ◽  
Vol 8 (1) ◽  
pp. 43 ◽  
Author(s):  
Geraldine Wai Bik Ng ◽  
Una Man Shu Chan ◽  
Patrick Chung Ki Li ◽  
William C. W. Wong
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Mediterranean Diet ◽  
Controlled Trial ◽  
Serum Triglyceride ◽  
Fat Distribution ◽  
Diet Group ◽  
Low Fat ◽  
Low Fat Diet ◽  
Randomised Controlled

Background: HIV and highly active antiretroviral therapies have been associated with changes in individuals’ lipid profiles and fat distribution (lipodystrophy). A pilot study was conducted for a randomised controlled trial to evaluate whether lipodystrophy in HIV patients can be controlled by adopting the low-fat and low-cholesterol diet or the modified Mediterranean diet. Methods: Forty-eight HIV patients were randomised into two diet groups. Thirty-six (75%) completed the 1-year pilot study with regular dietetic consultations, during which time lipid levels, weight, body mass index and fat distribution were recorded. Differences between and within groups were determined. Results: Undesirable body fat changes in the low-fat diet group included decreases in tricep skinfold (from 19.9 mm to 15.4 mm (P = 0.03)), hip circumference (from 93.6 cm to 91.7 cm (P = 0.01)) but a significant increase in waist-to-hip ratio (from 0.87 to 0.89 (P = 0.003)). Serum cholesterol increased significantly in the Mediterranean diet group at 9 and 12 months (from 4.6 to 5.06 mmol L−1 (P = 0.03) and 5.12 mmol L−1 (P = 0.01)) with no obvious change in the low-fat diet group. Serum triglyceride levels remained the same in the Mediterranean diet group, whereas it increased from 1.9 to 3.22 mmol L−1 (P = 0.07) in the low-fat diet group. Conclusions: A Mediterranean diet seems to have an advantage over the low-fat diet in maintaining serum triglyceride levels and avoiding lipodystrophy, but this advantage was offset by a rise in cholesterol level. Several procedural and methodological issues were identified which must be rectified before a similar large-scale trial taking place.

scholarly journals Study protocol: a prospective controlled clinical trial to assess surgical or medical treatment for paediatric type 2 diabetes (ST2OMP)

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e047766
Author(s):  
Amy S Shah ◽  
Michael A Helmrath ◽  
Thomas H Inge ◽  
Stavra A Xanthakos ◽  
Megan M Kelsey ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Medical Treatment ◽  
Medical Center ◽  
Institutional Review Boards ◽  
Controlled Clinical Trial ◽  
Haemoglobin A1c ◽  
Open Label ◽  
Beneficial Effects

IntroductionThe pathophysiology of type 2 diabetes (T2D) in youth differs from adults and conventional medical treatment approaches with lifestyle change, metformin, thiazolidinediones or insulin are inadequate. Metabolic bariatric surgery (MBS) improves multiple health outcomes in adults with T2D. Initial small, uncontrolled studies of Roux-en-Y gastric bypass have also suggested beneficial effects in adolescents. Definitive studies in youth with T2D are lacking, especially with the now more common form of MBS, vertical sleeve gastrectomy (VSG). The surgical or medical treatment for paediatric type 2 diabetes (ST2OMP) clinical trial was designed to test the hypothesis that VSG will more effectively reduce hyperglycaemic and diabetes comorbidities than the best currently available medical treatment incorporating state of the art pharmacotherapies. ST2OMP is also designed to better understand the pancreatic and enterohepatic mechanisms by which MBS improves diabetes and its associated comorbidities.Methods and analysisST2OMP is a prospective, open-label, controlled clinical trial that will recruit 90 postpubertal participants, age range 13–19.9 years, with body mass index ≥35 kg/m2 or >120% of 95th percentile and youth-onset T2D. The primary outcome is the per cent of youth achieving haemoglobin A1c <6.0% at 12 months postgroup allocation (post-VSG vs postmedical group allocation). Secondary outcomes include remission of comorbidities and measures of β-cell and incretin responses at 12 and 24 months post VSG versus AMT.Ethics and disseminationThe ST2OMP protocol was approved by the Cincinnati Children’s Hospital Medical Center and the University of Colorado Institutional Review Boards. Written informed consent is obtained prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations.Trial registration numberClinical Trials.Gov NCT04128995.

Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus®): a randomized open-label clinical trial

2020 ◽  
Vol 9 (4) ◽  
pp. 263-273
Author(s):  
Tatiana L Karonova ◽  
Anna A Mosikian ◽  
Alexander Y Mayorov ◽  
Igor E Makarenko ◽  
Svetlana T Zyangirova ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Trial ◽  
Immune Response ◽  
Type 1 Diabetes ◽  
Insulin Glargine ◽  
Open Label ◽  
Once Daily ◽  
Safety And Efficacy ◽  
Glucose Profiles

Aim: To compare safety (immunogenicity) and efficacy of GP40061 insulin glargine (GP-Gla) and Lantus® (Sanofi glargine, Sa-Gla) in people with diabetes mellitus. Materials & methods: This randomized open-label, 26-week clinical trial enrolled 180 Type 1 diabetes mellitus patients (HbA1c 6.5–12.0%), randomized 1:1 to once daily GP-Gla (n = 90) or Sa-Gla (n = 90). The primary end point was immune response at 26th week. Results: The frequency of immune response was similar in GP-Gla and Sa-Gla (p = 1.000). Groups were similar in terms of other safety end points. Mean HbA1c change from baseline was -0.66% for GP-Gla and -0.77% for Sa-Gla, and did not differ between groups (p = 0.326). Insulin doses, fasting plasma glucose and seven-point glucose profiles were similar between groups. Conclusion: GP-Gla and Sa-Gla demonstrated similar safety and efficacy. ClinicalTrials.gov Identifier: NCT04022993

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