John M. Jakicic, Donna H. Ryan, Jamy D. Ard, Patrick M. O'Neil, Robert F. Kushner, Holly R. Wyatt, Harold E. Bays, Frank L. Greenway, Sharon Leonard, Yael Kenan, Eti Ganon-Elazar, Thomas A. Wadden
Early response (ER) to treatment is predictive of longer-term weight loss. In this post hoc analysis, ER to an oral shape-shifting superabsorbent hydrogel capsule (Epitomee) combined with a lifestyle intervention was compared to placebo combined with a lifestyle intervention. Participants (age = 48.5 ± 12.5 and 48.6 ± 12.4; BMI = 34.1 ± 3.3 and 33.7 ± 3.4, in the Epitomee and placebo groups, respectively) were randomised to Epitomee (N = 138) or placebo (N = 141) with lifestyle intervention. Analyses included body weight measurements taken at baseline, week 8, and week 24. Of the 279 participants enrolled in the study, 250 (90% of the ITT population) provided weight data, including 124 participants in the Epitomee group and 126 in the placebo group. Participants with missing weight data at week 24 were classified as non-responders. Early response (ER) was defined as a weight loss of ≥ 2% at week 8. Weight loss at week 24 was greater in ER to Epitomee compared to placebo (9.3% ± 6.0% vs. 6.9% ± 4.3%; p < 0.0001). The odds ratio for ER to achieve > 5% weight loss at week 24 was 4.10 (95% CI: 1.02, 16.46) for Epitomee and 2.38 (95% CI: 0.62, 9.21) for placebo. A greater proportion of ER to Epitomee, compared to placebo, achieved > 5% (76% vs. 62%; p = 0.0472), ≥ 7% (61% vs. 38%; p < 0.0045) and ≥ 10% (39% vs. 17%; p < 0.0025) weight loss at week 24. ER response to Epitomee was associated with greater weight loss at 24 weeks compared to placebo. Monitoring ER to Epitomee and titrating treatment based on ER may enhance weight loss.
{"title":"Association of the Early Response to an Oral Shape-Shifting Superabsorbent Hydrogel Capsule With Weight Loss","authors":"John M. Jakicic, Donna H. Ryan, Jamy D. Ard, Patrick M. O'Neil, Robert F. Kushner, Holly R. Wyatt, Harold E. Bays, Frank L. Greenway, Sharon Leonard, Yael Kenan, Eti Ganon-Elazar, Thomas A. Wadden","doi":"10.1111/cob.70037","DOIUrl":"10.1111/cob.70037","url":null,"abstract":"<p>Early response (ER) to treatment is predictive of longer-term weight loss. In this post hoc analysis, ER to an oral shape-shifting superabsorbent hydrogel capsule (Epitomee) combined with a lifestyle intervention was compared to placebo combined with a lifestyle intervention. Participants (age = 48.5 ± 12.5 and 48.6 ± 12.4; BMI = 34.1 ± 3.3 and 33.7 ± 3.4, in the Epitomee and placebo groups, respectively) were randomised to Epitomee (<i>N</i> = 138) or placebo (<i>N</i> = 141) with lifestyle intervention. Analyses included body weight measurements taken at baseline, week 8, and week 24. Of the 279 participants enrolled in the study, 250 (90% of the ITT population) provided weight data, including 124 participants in the Epitomee group and 126 in the placebo group. Participants with missing weight data at week 24 were classified as non-responders. Early response (ER) was defined as a weight loss of ≥ 2% at week 8. Weight loss at week 24 was greater in ER to Epitomee compared to placebo (9.3% ± 6.0% vs. 6.9% ± 4.3%; <i>p</i> < 0.0001). The odds ratio for ER to achieve > 5% weight loss at week 24 was 4.10 (95% CI: 1.02, 16.46) for Epitomee and 2.38 (95% CI: 0.62, 9.21) for placebo. A greater proportion of ER to Epitomee, compared to placebo, achieved > 5% (76% vs. 62%; <i>p</i> = 0.0472), ≥ 7% (61% vs. 38%; <i>p</i> < 0.0045) and ≥ 10% (39% vs. 17%; <i>p</i> < 0.0025) weight loss at week 24. ER response to Epitomee was associated with greater weight loss at 24 weeks compared to placebo. Monitoring ER to Epitomee and titrating treatment based on ER may enhance weight loss.</p>","PeriodicalId":10399,"journal":{"name":"Clinical Obesity","volume":"16 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cob.70037","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144741401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bariatric surgery is the most clinically- and cost-effective intervention for severe obesity. However, without adequate follow-up, it can lead to nutritional deficiencies. Patients require life-long nutritional supplements and follow-up to prevent nutritional deficiencies from developing. This rapid systematic review is the first synthesis of case reports of patients with vitamin and micronutrient deficiencies at least 2 years following bariatric surgery, the point at which patients are typically discharged from specialist bariatric services. Eighty-three cases (74 studies) met inclusion criteria. Female patients accounted for 84% of the reports. Roux-en-Y Gastric Bypass (RYGB) was the most common procedure to have been performed, followed by biliopancreatic diversion (BPD). The most frequently reported deficiencies were vitamin A (n = 15), copper (n = 14) and vitamin D (n = 23). In some cases, vitamin replacement led to symptom resolution, but some preceded permanent disability or death. Fifty-one case reports detailed factors contributing to the development of the deficiency. These could be divided into patient factors or health care factors and provide areas to target interventions, including support to adhere to supplementation, appropriate follow-up, and health professional awareness.
{"title":"Nutritional Deficiencies Following Bariatric Surgery: A Rapid Systematic Review of Case Reports of Vitamin and Micronutrient Deficiencies Presenting More Than Two Years Post-Surgery","authors":"Sophie Haughton, Sarah Gentry, Helen M. Parretti","doi":"10.1111/cob.70035","DOIUrl":"10.1111/cob.70035","url":null,"abstract":"<p>Bariatric surgery is the most clinically- and cost-effective intervention for severe obesity. However, without adequate follow-up, it can lead to nutritional deficiencies. Patients require life-long nutritional supplements and follow-up to prevent nutritional deficiencies from developing. This rapid systematic review is the first synthesis of case reports of patients with vitamin and micronutrient deficiencies at least 2 years following bariatric surgery, the point at which patients are typically discharged from specialist bariatric services. Eighty-three cases (74 studies) met inclusion criteria. Female patients accounted for 84% of the reports. Roux-en-Y Gastric Bypass (RYGB) was the most common procedure to have been performed, followed by biliopancreatic diversion (BPD). The most frequently reported deficiencies were vitamin A (<i>n</i> = 15), copper (<i>n</i> = 14) and vitamin D (<i>n</i> = 23). In some cases, vitamin replacement led to symptom resolution, but some preceded permanent disability or death. Fifty-one case reports detailed factors contributing to the development of the deficiency. These could be divided into patient factors or health care factors and provide areas to target interventions, including support to adhere to supplementation, appropriate follow-up, and health professional awareness.</p>","PeriodicalId":10399,"journal":{"name":"Clinical Obesity","volume":"15 6","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cob.70035","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}