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Management of Obesity-Associated Type 2 Diabetes
Published in Emmanuel C. Opara, Sam Dagogo-Jack, Nutrition and Diabetes, 2019
Wanda C. Lakey, Lillian F. Lien, Mark N. Feinglos
A study of 668 obese participants placed on the protein-sparing modified fast diet demonstrated a mean weight loss from baseline of 21 ± 13 kg during the initial phase and 19 ± 13 kg during the refeeding phase [142]. Another study evaluated the effects of caloric restriction and weight loss on glycemic control and insulin resistance in obese patients with type 2 diabetes [143]. Six patients were placed on a protein-sparing modified fast diet for up to 6 months until a weight goal of less than 120% of ideal body weight was achieved, or cessation of further weight loss occurred. Six patients were assigned to the gastric bypass arm. Among the six patients in the diet arm, significant decreases occurred over the intervention period in the mean steady-state plasma glucose (from 377 to 208 mg/dL; P < .008) and the mean fasting insulin levels (from 31 to 17 μU/mL; P < .004).
The Effect of Ketogenic Diet on Weight Loss in Adult Patients with Cancer: A Systematic Review and Meta-Analysis of Controlled Clinical Trials
Published in Nutrition and Cancer, 2022
Marzieh Taftian, Sara Beigrezaei, Vahid Arabi, Amin Salehi-Abargouei
Literature search was performed in PubMed/MEDLINE, Web of Science (ISI), Scopus, and Google Scholar up to August 2020 without any date or language restrictions. The combination of medical subject headings (MeSH) and non-MeSH keywords was used to design the search strategy:: 1) (ketogenic and diet) OR “ketogenic” OR ketosis OR “ketone bodies” OR ketones OR “ketone body” OR (Low carb and Diet) OR (Low-carb and Diet) OR (“Low carbohydrate” and Diet) OR (“Low-carbohydrate” and Diet) OR (“carbohydrate‐restricted” and diet) OR “very low energy diet” OR “very low calorie diet” OR “very-low calorie diet” OR “protein sparing modified fast” OR "Atkins diet" OR "medium chain triglyceride diet" OR "medium-chain triglyceride diet" OR "low glycemic index " OR "low-glycemic index " OR "low glycemic load" OR "low-glycemic load" OR “high fat diet” OR “high-fat diet,” and 2) Neoplasia OR Neoplasm OR Neoplasms OR Tumors OR Tumor OR Cancer OR Cancers OR Malignancy* OR Benign]. Two investigators (MT and VA) independently screened the titles and abstracts to find the relevant studies according to inclusion and exclusion criteria and any disagreement was resolved by discussion with the third researcher (ASA). In addition, to detect additional related studies the references of included studies and related reviews were screened.
Regulatory experience of handling Risk Management Plans (RMPs) for medicinal products in the EU
Published in Expert Opinion on Drug Safety, 2021
Dianne Butler, Katarina Vucic, Sabine Straus, Amelia Cupelli, Benjamin Micallef, Anthony Serracino-Inglott, John-Joseph Borg
The amendments made to the EU pharmacovigilance legislation in 2010 impacted the requirements for a marketing authorization. RMPs are to be included in all new applications [3]. Today, the RMP is also a requirement for innovative medicinal products as well generic medicinal products. The requirement of RMP is independent of the route of authorization as it is required both in centrally authorized as well as nationally authorized medicinal products. The change in legislation has significant implications for applicants, holders of EU marketing authorizations and national competent authorities within MSs. Such changes included; a pharmacovigilance system master file (PSMF) was introduced instead of a detailed description of the PhV system, the RMP became a requirement for all new products, post-authorization measures were enhanced with post-authorization safety studies (PASS) and post-authorization efficacy studies (PAES) became legally binding [3].