187-LB: Glucose Response Curve (GRC) Shapes in Mixed Meal Tolerance Tests (MMTTs) and Prediction of Response to Intervention in the TrialNet New-Onset Clinical Trials

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 187-LB
Author(s):  
NOURAH NAJI ALMUTLAQ ◽  
MARIO A. CLEVES ◽  
STEPHEN E. GITELMAN ◽  
LINDA DIMEGLIO ◽  
JAY M. SOSENKO ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Response To Intervention ◽  
Response Curve ◽  
Mixed Meal ◽  
Prediction Of Response ◽  
Glucose Response ◽  
New Onset

1663-P: Monophasic Glucose Response Curve Reflective of Glucose Intolerance in Young Mexican Americans

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1663-P
Author(s):  
JASMIN JENKINS ◽  
CESAR MEZA ◽  
MANUEL AMADOR ◽  
ANDREW J. MCAINCH ◽  
SUDIP BAJPEYI
Keyword(s):  
Glucose Intolerance ◽  
Mexican Americans ◽  
Response Curve ◽  
Glucose Response

scholarly journals SAT-418 Finding the Needles in the Haystack: Harnessing the Electronic Health Record to Find Thyroid Immune Related Adverse Events

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Zoe Quandt ◽  
Laura Trupin ◽  
Michael Evans ◽  
Gabriela Schmajuk ◽  
Mark Stuart Anderson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Electronic Health Record ◽  
Real World ◽  
Immune Checkpoint ◽  
Thyroid Disease ◽  
Thyroid Dysfunction ◽  
Health Record ◽  
The Real ◽  
New Onset

Abstract Background: Immune checkpoint inhibitors (CPIs) are being used to effectively treat a growing number of cancers but can cause immune related adverse events (irAE). Thyroid dysfunction is the most common endocrine irAE. A meta-analysis of clinical trials estimated that following CPI exposure, 6.6% will become hypothyroid and 2.9% will have hyperthyroidism1. It is unclear if this reflects the real-world incidence of these irAEs. We used electronic health record (EHR) data to identify patients who developed thyroid dysfunction after CPI to estimate the real-world incidence of these irAEs. Methods: Data were derived from the EHR of a large U.S. academic center. We identified subjects treated with CPIs between 2012 and 2018 and excluded those with thyroid cancer or pre-existing thyroid disease. Thyroid dysfunction was identified as either a TSH > 10, an abnormal free T4 or a prescription for thyroid hormone replacement or anti-thyroid medication. Those with thyroid dysfunction were then categorized as having pre-existing disease or a new-onset thyroid irAE based on the timing of CPI initiation. Logistic regression was used to evaluate the association of thyroid irAE with age, gender, CPI and type of cancer. Results: In total, 1146 individuals without pre-existing thyroid disease that received CPIs were assessed. Pembrolizumab was the most common treatment (45%), followed by nivolumab (20%). Less than 10% of subjects received atezolizumab, durvalumab, ipilimumab monotherapy, combined ipilimumab/nivolumab, or other combinations of CPIs. Melanoma was the most common cancer treated (32%), followed by non-small cell lung cancer (13%). The prevalence of any other cancer was < 10% each. Overall, 19% developed thyroid irAEs. After adjustment for gender and age, the type of cancer was significantly associated with new onset thyroid dysfunction (p=0.01). The rates of thyroid irAEs ranged from 10% in glioblastoma to 40% in renal cell cancer. Although there was no significant association between irAEs and specific CPIs in the overall analysis, thyroid irAEs were more common in subjects who received combined ipilimumab/ nivolumab (31%) compared to pembrolizumab (18%, p=0.03), nivolumab (18%, p<0.01) and ipilimumab (15%, p=0.02). Conclusion: Thyroid irAEs are much more common in real world practice than in clinical trials and there is emerging evidence that certain cancer types incur a higher risk of thyroid irAEs even after adjustment for CPI exposure. Clinicians and patients should be educated about these risks. Future work should focus on exploring the reasons underlying the differing rates of thyroid irAEs among different cancers including effect on cancer outcomes. 1Barroso-Sousa et al. Incidence of Endocrine Dysfunction Following the Use of Different Immune Checkpoint Inhibitor Regimens. JAMA Oncol. 2017; 02215: 1–10.

scholarly journals Qualitative study of barriers to clinical trial retention in adults with recently diagnosed type 1 diabetes

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e022353 ◽  
Author(s):  
Catherine Henshall ◽  
Parth Narendran ◽  
Robert C Andrews ◽  
Amanda Daley ◽  
Keith A Stokes ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Type 1 Diabetes ◽  
Qualitative Study ◽  
Qualitative Methodology ◽  
Cell Function ◽  
Retention Rates ◽  
Newly Diagnosed ◽  
Advance Study ◽  
New Onset

ObjectivesRegular physical exercise may preserve β cell function in newly diagnosed adults with type 1 diabetes (T1D). However, clinical trials to test this theory require the recruitment and retention of adults with new-onset T1D, which can be challenging. We sought to determine the overall experiences of newly diagnosed adults with T1D in an exercise study, to understand issues that influence the retention of trial participants in such studies.DesignQualitative methodology using individual face-to-face (n=6) and telephone interviews (n=14). Interview transcripts were thematically analysed using the framework method.SettingThe study took place at five participating UK hospitals.ParticipantsTwenty participants, aged 19–55 years, in the Exercise for Type 1 Diabetes study were interviewed to explore their study experiences and identify motivators and deterrents towards the study. Participants in control and intervention arms were interviewed, as were people with T1D who had completed (n=16) and withdrawn (n=4).ResultsParticipants revealed barriers and facilitators to retention; the majority were generalisable to clinical trials of people with newly diagnosed T1D. Coming to terms with a diagnosis of T1D, lack of time, work pressures, level of health professional support, volume, clarity and consistency of information and feedback and a desire for knowledge about their condition were all cited as influencing factors to trial retention.ConclusionsTo our knowledge, this is the first qualitative study to examine the experience of being involved in an exercise trial by people with T1D. Findings suggest appointments could be shorter, available outside of working hours and planned longer in advance; study information should be clear, consistent and in electronic and paper formats; questionnaires need minimising; healthcare support and feedback needs providing regularly; thought is required around how to support non-exercising arm participants. These considerations may improve participant retention rates in new-onset T1D studies.

scholarly journals PET/CT and the Response to Immunotherapy in Lung Cancer

2020 ◽  
Vol 13 (3) ◽  
pp. 177-184 ◽  
Author(s):  
Laura Evangelista ◽  
Matteo Sepulcri ◽  
Giulia Pasello
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Fdg Pet ◽  
Response To Therapy ◽  
Prediction Of Response ◽  
Lung Cancer Patients ◽  
Pet Ct ◽  
Fdg Pet Ct

Objective: In recent years, the introduction of immune checkpoint inhibitors has significantly changed the outcome of patients affected by lung cancer and cutaneous melanoma. Although the clinical advantages, the selection of patients and the evaluation of response to immunotherapy remain unclear, the immune-related Response Evaluation Criteria in Solid Tumor (irRECIST) was proposed as an update of the RECIST criteria for the assessment of response to immunotherapy. However, morphological images cannot predict early response to therapy that represents a challenge in clinical practice. 18F-FDG PET/CT before and after immunotherapy has an indeterminate role, demonstrating ambiguous results due to inflammatory effects secondary to activation of the immune system. The aim of the present review was to analyze the role of PET/CT as a guide for immunotherapy, by analyzing the current status and future perspectives. Methods: A literature search was conducted in order to select all papers that discussed the role of PET/CT with FDG or other tracers in the evaluation or prediction of response to immunotherapy in lung cancer patients. Results: Many papers are now available. Many clinical trials have demonstrated the efficacy of immunotherapy in lung cancer patients. FDG PET/CT can be used for the prediction of response to immunotherapy, while its utility for the evaluation of response is not still clearly reported. Moreover, the standardization of FDG PET/CT interpretation is missing and different criteria, such as information, have been investigated until now. Conclusions: The utility of FDG PET/CT for patients with lung cancer undergoing immunotherapies is still preliminary and not well addressed. New agents for PET are promising, but large clinical trials are mandatory.

scholarly journals Reduced glycaemic and insulinaemic responses following trehalose ingestion: implications for postprandial substrate use

2009 ◽  
Vol 102 (10) ◽  
pp. 1395-1399 ◽  
Author(s):  
Judith G. P. van Can ◽  
T. Herman IJzerman ◽  
Luc J. C. van Loon ◽  
Fred Brouns ◽  
Ellen E. Blaak
Keyword(s):  
Metabolic Response ◽  
Energy Content ◽  
Insulin Response ◽  
Area Under The Curve ◽  
Fat Oxidation ◽  
Mixed Meal ◽  
Glucose Response ◽  
Substrate Use ◽  
Total Energy Content ◽  
Single Blind

The proposed impact of slowly digestible sources of dietary carbohydrate in reducing the risk of developing obesity and related metabolic disorders remains unclear. The aim of the present study was to compare the postprandial metabolic response to the ingestion of glucose v. trehalose. We hypothesised that the reduced digestion and absorption rate of trehalose is accompanied by an attenuated glycaemic and insulinaemic response, leading to a less inhibited postprandial fat oxidation rate. In a randomised, single-blind, cross-over study, ten overweight subjects ingested two carbohydrate drinks (75 g carbohydrate equivalents of trehalose or glucose) following an overnight fast (08.40 hours) and together with a standardised mixed meal (12.30 hours; 25 % total energy content was provided as either glucose or trehalose). Blood samples were collected before ingestion and every 30 min thereafter for a period of 3 h; substrate use was assessed by indirect calorimetry and expired breath samples were collected. Ingestion of carbohydrates with a mixed meal resulted in a lower peak glucose response and a lower change in area under the curve (ΔAUC) following trehalose when compared with glucose. Differences in peak insulin response and ΔAUC were observed with trehalose when compared with glucose during the morning and afternoon. These differences were accompanied with a reduced carbohydrate oxidation after trehalose when ingested as a drink, whilst no significant differences in fat oxidation between drink were observed.

scholarly journals Prolonged Honeymoon Period in a Thai Patient with Adult-Onset Type 1 Diabetes Mellitus

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Yotsapon Thewjitcharoen ◽  
Ekgaluck Wanothayaroj ◽  
Haruethai Jaita ◽  
Soontaree Nakasatien ◽  
Siriwan Butadej ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Regular Exercise ◽  
Adult Onset ◽  
Mixed Meal ◽  
Thai Patient ◽  
Low Carbohydrate ◽  
Stimulation Tests ◽  
Meal Stimulation ◽  
New Onset

Context. The “honeymoon” phase among people with type 1 diabetes mellitus (T1DM) refers to the period (mostly less than 1 year) in which beta-cells remain functional and are able to produce insulin to maintain good glycemic control shortly following the development of diabetes. This phenomenon is still not completely understood. Previous studies have shown that the absence of diabetic ketoacidosis (DKA) at initial presentation, short duration of symptoms, older age at presentation, and strenuous exercise could be potential factors that influence the honeymoon phase. Objective. To describe a usual case of adult-onset T1DM with prolonged honeymoon period for more than 5 years. Methods. Repeated mixed meal stimulation tests for a period of 6–12 months together with monitoring pancreatic autoantibodies and laboratory data were followed following the onset of diagnosis. Results. We report a 24-year-old Thai patient with T1DM with sustained remission without antidiabetic medication for more than 5 years while maintaining low-carbohydrate intake and regular exercise. Repeated mixed meal stimulation tests for a period of 6–12 months revealed preserved beta-cell functions. Interestingly, repeated pancreatic autoantibodies at 5 years after diagnosis still showed positive anti-GAD, anti-IA2, and anti-ZnT8. Conclusion. Restored beta-cell function with complete insulin withdrawal in new-onset T1DM has been reported in very few cases with some common factors as in our patient (low-carbohydrate intake with regular exercise). Delaying autoimmune activity by reducing metabolic load in newly diagnosed T1DM might play a role in maintaining the honeymoon period and could lead to an innovative therapeutic option in new-onset T1DM.

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