Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Digestive System Diseases

Rare Diseases

Diabetes Mellitus

Prediabetic State

Breast Neoplasms

Pancreatic Neoplasms

Glucose Intolerance

Hyperglycemia

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Pancreatic Cancer

A blinded continuous glucose monitor (specifically a Freestyle Libre Pro) will be worn for a 14 day period by patients during the first and third cycles of breast neoadjuvant chemotherapy. At the end of that period (after completion of the one round of chemotherapy) readings will be downloaded from the sensor and the sensor will be removed. Readings will be evaluated by the treating endocrinologist as well as the study team and appropriate clinical interventions.

A blinded continuous glucose monitor (specifically a Freestyle Libre Pro) will be worn for a 14 day period by patients during the first and third cycles of pancreatic chemotherapy. At the end of that period (after completion of the one round of chemotherapy) readings will be downloaded from the sensor and the sensor will be removed. Readings will be evaluated by the treating endocrinologist as well as the study team and appropriate clinical interventions.

James Flory, MD

The purpose of this study is to see if continuous glucose monitoring can identify how often people who have pre-diabetes or medical obesity or well-controlled diabetes experience very high glucose values while receiving chemotherapy for breast cancer or pancreatic.

Glucose Monitoring to Predict and Treat High Glucose Levels After Steroid Treatment

Continuous Glucose Monitoring For Prediction and Treatment of Steroid-Induced Hyperglycemia

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

glucose \> 400 mg/dL for over 3 contiguous hours

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Obesity

Body Weight

Weight Loss

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Hypoglycemic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Liraglutide

Glucagon-Like Peptide 1

Glucagon

Glucagon-Like Peptide-1 Receptor Agonists

Incretins

Hormones

Hormone Antagonists

Start injection liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg liraglutide SQ daily

Start injection of placebo liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg placebo liraglutide SQ daily

daily sc injection of liraglutide with final dose of 3mg daily

Liraglutide Pen Injector [Saxenda]

daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo

Placebo Liraglutide Pen Injector

Peggy Dean, PharmD

There is a growing need to develop pharmacologic interventions to improve metabolic function in women with polycystic ovary syndrome (PCOS). Given that PCOS is a frequent condition and weight loss is essential but difficult to achieve, it is important to study if the effect on body weight reported in other studies can be confirmed in a selected population of hyperandrogenic patients, especially with medications currently approved for weight reduction. High dose liraglutide alone results in significant weight reduction in obese women without PCOS. There is limited data on weight loss with high dose liraglutide in non-diabetic females with PCOS treated with this agent . Studies on the effect of anti-obesity medication combined with lifestyle changes on body weight and composition and androgen excess in obese women diagnosed with PCOS are lacking. The investigators aim to elucidate the most efficacious weight reduction regime in obese PCOS women. The investigators further hope to determine which treatment(s) addressing the multifaceted disturbances of this disorder in patients with PCOS and obesity emerges as the preferable therapy.

The drug, liraglutide 3.0 mg was approved for chronic weight management in management in obese adults with an initial BMI of 30 kg/m2 or greater or in overweight adults BMI of 27 kg/m2 or greater with at least one weight-related co-morbid condition as an adjunct to a reduced-calorie diet and increased physical activity. Liraglutide is an acylated human glucagon-like peptide -1 (GLP-1) analog that binds to and activates the GLP-1 receptor. It lowers body weight through decreased caloric intake while stimulating insulin secretion and reducing glucagon via a glucose-dependent mechanism. For obesity management, patients may lose weight with GLP-1 receptor agonists due to other unique actions. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) can slow gastric emptying and increase satiety. While predictors of weight loss success for the general population are available (protein intake, weight loss medications), predictors of weight loss success may differ between normal and hyperandrogenic women. Glucagon-like peptide 1 agonists are linked with dose dependent weight lowering potential in different obesity related populations. The weight loss effects of GLP-1RAs previously demonstrated in diabetic and obese non-diabetic patients, offer a unique opportunity to expand the medical options available to patients with PCOS.

Given this lack of information, the aim of the present study was to investigate the effects of liraglutide 3mg vs. placebo on body composition as well as hormonal and metabolic features in non-diabetic obese women with PCOS.The non-diabetic obese female with PCOS offers a unique model to study the relationship between insulin resistance and adiposity. The investigators propose a double-blind, placebo-controlled 30-week trial designed to directly examine the therapeutic effects of liraglutide 3 mg (LIRA 3 mg) compared to placebo on body weight, hormonal and cardiometabolic parameters in obese non-diabetic women with PCOS. All patients will receive diet and lifestyle counseling, including advice on exercise commencing during the lead-in period and continuing throughout the study. In this study, the investigators will examine the efficacy of LIRA 3mg on body weight and body composition, reproductive function metabolic parameters and cardiovascular risk factors in a well-defined group of pre-menopausal obese non-diabetic women with hyperandrogenism, focusing on the relationship to obesity and insulin resistance.

Patients must be female to have the disorder being studied since it involved the female reproductive system

Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS

A Randomized Placebo-controlled Double Blind Trial of Liraglutide 3 mg [Saxenda] on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With Polycystic Ovary Syndrome (PCOS)

Treatment impact on change in body weight after 32 weeks of treatment.

Drug treatment effect on free androgen levels as calculated as FAI= total testosterone (T) concentrations divided by sex hormone binding globulin (SHBG) levels. A higher score indicates a worse outcome (more androgenic).

Treatment effect on reducing body weight expressed as percent body weight loss from baseline

Frequency of patients achieving 5% weight loss from baseline with treatment

Frequency of patients with at least 10% reduction in body weight from baseline

Treatment effect on loss of WC (abdominal adiposity) with drug treatment

Change in central adiposity with treatment as measured by WHR. A reduction in ratio indicates a decrease in truncal fat.

Treatment effect on loss of central adiposity as determined by WHt ratio. The lower the ratio indicates less abdominal adiposity.

Treatment effect on reduction of fat mass (kg)

Treatment effect on reduction of percent body fat by DXA

Treatment impact on AGR, measure of central adiposity, as determined by DXA. A lower AGR indicates a reduction in central adiposity.

Treatment impact on TLR after 32 weeks. A reduction in TLR indicates a loss of central fat.

Drug treatment impact on normalization of cycle frequency (cycle every 28-30 days). All cycle data is expressed as number of menses annualized to one year.

Drug treatment effect on total testosterone concentrations

Treatment efficacy in reducing adrenal hyperandrogenism

Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT)

Treatment effect on MBG measured during the oral glucose tolerance test. A decrease in MBG shows improvement in glycemia.

Treatment effect on the HOMA-IR which is an insulin resistance measured derived from fasting blood glucose and insulin . The higher the number the more insulin resistant.

The SI OGTT is a measure of peripheral insulin sensitivity derived from the insulin and glucoses measured during an OGTT. A increase in SI OGTTindicates greater insulin sensitivity

Treatment effect on insulin secretion from 0 to 30 minutes after glucose load corrected for by fasting insulin sensitivity. A higher score shows improved first phase insulin secretion in response to glucose.

Treatment effect on an estimation of Beta cell compensatory function, the IS-SI is derived by applying the concept of the disposition index to measurements obtained during the 2 hour OGTT and calculated as the index of insulin secretion factored by insulin sensitivity. A higher score shows improved pancreatic beta cell function relative to insulin sensitivity.

Treatment impact on improving total cholesterol levels

Impact of treatment on HDL levels after 32 weeks of treatment

Drug effect of TRG levels after treatment

Treatment impact on TRG/HDL-C ratio which is a simple measure to estimate insulin action. A decrease in ratio indicates improvement in insulin sensitivity.

Treatment impact on the TyG index which estimates insulin resistance. A reduction in TyG indicates an improvement in insulin action.

Treatment impact on systolic blood pressure

Treatment impact on reducing diastolic blood pressure

Novo Nordisk A/S

Woman's

Scientific Director of Research

Start injection liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg liraglutide SQ daily

Liraglutide Pen Injector \[Saxenda\]: daily sc injection of liraglutide with final dose of 3mg daily

Liraglutide Pen Injector (Saxenda)

Start injection of placebo liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg placebo liraglutide SQ daily

Placebo Liraglutide Pen Injector: daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Body mass Index

Director of Research

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Glucose Monitoring to Predict and Treat High Glucose Levels After Steroid Treatment	NCT04210128	Breast Cancer Pancreatic Canc... Diabetes Pre Diabetes		18 Years -	Memorial Sloan Kettering Cancer Center
Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS	NCT03480022	Pre Diabetes Polycystic Ovar... Obesity Android	Liraglutide Pen... Placebo Liraglu...	18 Years - 45 Years	Woman's
Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS	NCT03480022	Pre Diabetes Polycystic Ovar... Obesity Android	Liraglutide Pen... Placebo Liraglu...	18 Years - 45 Years	Woman's

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