Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Carcinoma

Weight Loss

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Obesity

Body Weight

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Body Weight Changes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Ovarian Cancer

Ovarian Epithelial Cancer

women with ovarian and/or endometrial cancer and weight loss will have muscle, adipose tissue, ovarian tumor and blood samples

women scheduled for an intervention for benign ovarian/ endometrial disease and no weight loss will have muscle, adipose tissue and blood samples

Blood samples, muscle biopsy, adipose tissue samples and ovarian cancer tumor sample

Samples

Lobna OULDAMER, MD, PhD

the aim is to study skeletal muscle metabolism alterations métaboliques associated with weight loss in women with ovarian and/or endometrial cancer according to BMI.

Skeletal Muscle Energy Metabolism in Women With Weight Loss and Ovarian and/or Endometrial Cancer With Weight Loss

Study of Differences in Skeletal Muscle Energy Metabolism Alterations in Women With Weight Loss and Ovarian and/or Endometrial Cancer Based on the Body Mass Index

Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

* Quantification of lipids on electron microscope
* Type of muscular fibers
* Analyze of gene expression and proteins involved in 1/ Mitochondrial metabolism 2/ lipid metabolism and 3/ muscular proteolysis by RTqPCR with SyBR Green and Western Blot

adipose tissue composition (fatty acids quantification, sterols, steroids)

* RT-qPCR quantification of molecules involved in lipid metabolism (synthesis, transport) and in inflammation (immune profile and cytokines)
* RTqPCR analysis, western blot and immunohistochemical expression of markers of transformation into brown adipose tissue
* in specific milieu, in vitro experimentation on skeletal muscular cells

* lipid composition (fatty acids quantification, sterols, steroids)
* RT-qPCR quantification of molecules involved in lipid metabolism (synthesis, transport) and in inflammation (immune profil and cytokines)
* culture of tumour cells to evaluate resistance to chemotherapy (platinum)

assessment of body composition (fat and muscle compartments)

Inserm U1069 - Team Nutrition, Growth and Cancer

University Hospital, Tours

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Chronic Graft Versus Host Disease

Micronutrients

All Drugs and Chemicals

Urological Agents

Vitamins

Ascorbic Acid

Adrenergic Agents

Mirabegron

Adrenergic Agonists

Adrenergic beta-3 Receptor Agonists

Adrenergic beta-Agonists

Neurotransmitter Agents

Vitamin C

Women will take 100mg daily for 4 weeks. Men will take 200mg daily for 4 weeks. The medication is available in 50 mg tablets.

Males will be randomized to take placebo versus active drug (mirabegron). Those taking placebo will take 4 tablets each day to mirror to active group (taking 4 tablets of 50 mg each).

B Complex Plus Vitamin C Tablets

Ashley M Schmitz, C.R.N.P.

Aaron M Cypess, M.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Background:

Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy.

Objective:

To learn more about how BAT works to burn energy.

Eligibility:

People ages 18-40 with a body mass index between 18 and 40

Design:

Participants will be screened with:

Medical history

Physical exam

Blood, urine, and heart tests

Dietitian interview

Participants will have an overnight baseline visit. This includes:

Repeats of screening tests

Exercise test

Scans. For one scan, a radioactive substance is injected into the arm.

FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other.

Metabolic suite: Participants stay 18 19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature.

Optional fat biopsy: A small piece of tissue is removed with a needle.

Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo.

All participants will have a visit after 2 weeks of the pills. They will repeat the screening tests.

Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests.

Participants will keep food and medication diaries.

Participants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests.

Background issues and controversies

More than ever before, there is a rise in the rates of obesity and diabetes. As opposed to white fat which stores excess calories, brown fat - also known as brown adipose tissue or BAT - consumes this energy to generate heat. In settings of increased food consumption and cold-exposure, studies show that human BAT becomes more active, potentially combatting weight gain. Other emerging evidence indicates that human BAT may be an endocrine organ, releasing hormones into the blood and regulating other organs like skeletal muscle, liver, and the insulin-releasing pancreatic Beta-cell. However, alongside these promising studies are those people who believe that there is not enough BAT in humans to be functionally relevant, and it contributes little to heat generation or overall health.

Purpose/Rationale of the proposed study

One of the principal reasons for skepticism about the ability to utilize human BAT is that there is not very much compared to smaller animals in which BAT activation has shown such promise. Therefore, a critical step is to develop medicines that can grow BAT in people and evaluate what kind of health benefits can be achieved.

Specific objectives

This study will administer the clinically-available beta3-AR agonist, mirabegron (Myrbetriq(R), Astellas Pharma). We will determine whether we can increase BAT volume and activity in people after they have taken this medication daily for four weeks. Our current goal is to see if chronic administration of mirabegron leads to an increase in BAT volume and metabolic activity and if it produces health benefits.

Key elements of what is involved

At the beginning of the study, the participants will undergo a series of tests to determine their baseline amounts of BAT, blood sugar status, and levels of specified hormones. The testing will take place over the course of two to three days while an inpatient on the Metabolic Patient Care Unit at the NIH Clinical Center. Depending on the Cohort, participants will then take the medication alone for four weeks or both the medication and placebo for four weeks each, during which time they will continue their standard daily routines. At two weeks after starting placebo or mirabegron, participants will return for one day for the assessment of any interim changes and to validate safety. At the end of each set of four weeks there will be a second set of inpatient testing over two to three days. Participants will be brought back two weeks after finishing the study for a follow-up safety visit, at which time they will receive an ECG and heart rate monitoring.

Primary outcomes

The primary outcome is either the change in BAT metabolic activity as measured by 18FFDG PET/CT or glucose infusion rate as measured by a hyperinsulinemic euglycemic clamp. Secondary endpoints will examine multiple other factors, including body weight, fat mass, glucose tolerance, changes in levels of hormones, and improved liver function.

The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists

.Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).

Change in brown adipose tissue (BAT) metabolic activity as measured by 18FFDG PET/CT

Change in glucose infusion rate, as measured by the hyperinsulinemic euglycemic clamp

Change in metabolic health parameters including body weight, fat mass, glucose tolerance, changes in levels of hormones, and improved liver function

Changes in glucose infusion rate, as measured by the hyperinsulinemic euglycemic clamp

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Skin and Connective Tissue Diseases

Overweight

Breast Neoplasms

Breast Diseases

Skin Diseases

Overnutrition

Nutrition Disorders

Acute Graft Versus Host Disease

Subjects will complete the Sedentary control testing sessions, have a 7-14 day washout period, and then complete the REx

Subjects will complete the REx testing sessions, have a 7-14 day washout period, and then complete the Sedentary control

REx condition: Participants will complete a whole-body REx workout consisting of 1-set to failure (e.g. RPE of 9-10 on 10-point scale on final reps) on 12 exercises in the Exercise Research Laboratory (located in the CTRC), with a 3-minute rest between exercises. Participants will complete the following exercises: leg press; leg extension; leg curl; hip abduction; hip adduction; chest press; overhead press; seated row; overheard pulldowns and assisted triceps dips on Cybex resistance equipment; barbell calf raises on a Smith machine; and dumbbell biceps curls. Resistance for the REx trial will be determined based on the exercise familiarization session. Specifically, we will target a resistance level needed for each participant to complete \~12-15 repetitions per exercise, using proper form, with an RPE of 9-10 on a 10-point scale on final reps. This protocol eliminates the need for max testing in order to set an exercise protocol off of a specific intensity based on % of 1RM.

REx Condition First

Sedentary control condition: Participants will sit quietly in a seated position for the entire duration of this condition.

Sedentary Control Condition First

The overall aim of this research is to investigate the acute effects of resistance exercise (REx) on the hormonal and behavioral indices of energy balance regulation in breast cancer survivors. This pilot study is designed to provide preliminary data to support future exercise interventions with more comprehensive energy balance profiling.

After screening, eligible and consented participants will complete baseline evaluations of REE, body composition, and subjective questionnaires to assess energy balance. Eligible and interested individuals will attend an exercise familiarization session in the two weeks before the initial study visit. Individuals will then be randomized to either sedentary control/REx or REx/sedentary control in a 1:1. A washout period of approximately 7-14 days will separate testing sessions.

A randomized cross-over short-term study design was chosen to assessment to profile appetite, energy intake, and physical activity in controlled and free-living settings while also reducing participant burden (as opposed to a long-term intervention). Participants will serve as their own controls, thereby circumventing inter-individual variation in physiology that may confound results. It is anticipated that responses to acute exercise will be amplified in chronic interventions and may therefore be used as a basis for generating hypotheses on the regulation of certain energy balance components. The study will end after the completion of 3 days of dietary intake recall and physical activity measurement for the last participant.

Individuals will be randomized to either sedentary control/REx or REx/sedentary control in a 1:1 manner using online software (http://www.randomization.com).

Appetite and Exercise in Breast Cancer Survivors

The Effects of Acute Resistance Exercise on Energy Balance Regulation Among Breast Cancer Survivors

REE will be measured for 20-25 minutes after a period of 30 minutes of quiet rest using an indirect calorimeter with ventilated hood (Parvo Medics metabolic cart). This test measures oxygen consumed and carbon dioxide exhaled to calculate REE (in kilocalories/day) using the Weir formula.

Data on participant's FM will be collected using a full body dual X-ray absorptiometry (DEXA; Hologic Delphi-W, Hologic Inc., Bedford, MA). The scanner will be calibrated according to the manufacturer's guidelines. All participants will undergo a pregnancy test before body composition testing. Body composition variables will be expressed in absolute terms and controlling for height (e.g. FM index: FM \[kg\]/height \[m2\])

Data on participant's FFM will be collected using a full body dual X-ray absorptiometry (DEXA; Hologic Delphi-W, Hologic Inc., Bedford, MA). The scanner will be calibrated according to the manufacturer's guidelines. All participants will undergo a pregnancy test before body composition testing. Body composition variables will be expressed in absolute terms and controlling for height (e.g. FFM will also be expressed in relation to FM (FM:FFM).

Additional blood for a single assessment of estradiol (Beckman Coulter) and progesterone (Beckman Coulter) will be collected at baseline during the first study visit to control for these hormones in the statistical analyses.

Ghrelin will be collected through serial IV collection. Each serum sample will be stored at -80C until analysis Radioimmunoassays will be used to determine serum total ghrelin (Milliipore). Total AUC will be calculated with the Trapezoid method, using all time points over the three hours following the control meal.

PYY will be collected through serial IV collection. Each serum sample will be stored at -80C until analysis Radioimmunoassays will be used to determine PYY (Millipore). Total AUC will be calculated with the Trapezoid method58, using all time points over the three hours following the control meal.

Appetite Ratings will be completed using 100 mm visual analogue scale (VAS) questions (hunger, fullness, and desire to eat) at time points described above. Total AUC will be calculated using the Trapezoid method.

Subjects will rate 'food appeal', 'food pleasantness', and 'desire to eat' of validated hedonic and non-hedonic food items using the ImageRate software with 0-100mm VAS scales.

Acute ad libitum EI will be measured during the buffet lunch via the weight and measure method by the dietary staff at the CTRC to measure energy and macronutrient intake following the REx and control conditions. The buffet lunch will consist of 15% more food than predicted requirements and the option to get more food as desired.

Activity and sedentary behaviors will be measured with ActivPAL accelerometers for 3 days after each study visit

Colorado Clinical & Translational Sciences Institute

National Cancer Institute (NCI)

National Center for Advancing Translational Sciences (NCATS)

University of Colorado, Denver

Digestive System Diseases

Malnutrition

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

the intervention, specific to the study, is to take samples on patients with advanced gastrointestinal cancer

the intervention, specific to the study, is to take samples on non-undernourished patients supported for adjuvant chemotherapy as part of colorectal cancer

Blood samples, muscle biopsy and sample of hair

Thierry LECOMTE, MD-PhD

Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the energy balance that leads to a gradual mobilization of energy reserves in the body and to increasing deterioration of the nutritional status of patients. This will thus significantly reduce quality of life and survival of patients with a lower tolerance to cancer treatments. Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or not explored, which could explain that there is still no satisfactory therapeutic solution to halt the gradual deterioration of the nutritional status of patients. In this sense, apart from preclinical data obtained in animal models, there is currently no clinical study on the functioning of skeletal muscle energy metabolism in undernourished patients suffering of cancer.

Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

Study of Alterations in Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

Quantification of muscle lipid droplets by electron microscopy

Analysis of the expression of target genes and proteins involved in 1/ mitochondrial metabolism 2/ lipid metabolism 3/ the regulation of energy metabolism and 4/ muscle proteolysis by RTqPCR with SYBR Green and by Western Blot

Determination of body composition ( fat mass / lean mass ) by an imaging method scannographic

Determining the isotopic composition of nitrogen hair spectrometry .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Skeletal Muscle Energy Metabolism in Women With Weight Loss and Ovarian and/or Endometrial Cancer With Weight Loss	NCT03027479	Weight Loss Ovarian Carcino... Endometrial Car...	Samples	18 Years -	University Hospital, Tours
Skeletal Muscle Energy Metabolism in Women With Weight Loss and Ovarian and/or Endometrial Cancer With Weight Loss	NCT03027479	Weight Loss Ovarian Carcino... Endometrial Car...	Samples	18 Years -	University Hospital, Tours
The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists	NCT03049462	Polycystic Ovar...	Mirabegron B Complex Plus ...	18 Years - 40 Years	National Institutes of Health Clinical Center (CC)
Appetite and Exercise in Breast Cancer Survivors	NCT04300478	Overweight Breast Cancer Obesity	REx Condition F... Sedentary Contr...	18 Years - 45 Years	University of Colorado, Denver
Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer	NCT02573974	Undernutrition Gastrointestina...	Samples	18 Years - 80 Years	University Hospital, Tours

Spots Global Cancer Trial Database for energy metabolism