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Metabolic Diseases clinical trials

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NCT ID: NCT04824872 Not yet recruiting - Hypoglycemia Clinical Trials

Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

Start date: March 2022
Phase: Phase 2
Study type: Interventional

The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects

NCT ID: NCT04820933 Not yet recruiting - Clinical trials for Cardiovascular Risk Factor

Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV

Start date: July 1, 2021
Phase: Early Phase 1
Study type: Interventional

This research application will explore the impact of the Non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine in the setting of established Nucleoside reverse transcriptase inhibitors (NRTIs) backbone [Tenofovir alafenamide (TAF) / Emtricitabine (FTC) as a possible therapeutic strategy to minimize the detrimental impact of ART-related toxicities on metabolism and instigators of atherosclerosis. Given the possible favorable role of NNRTI in pathogenesis of HIV-related dyslipidemia and cardiovascular disease (CVD), this research will provide mechanistic insights into HIV pathogenesis and safety data regarding doravirine (DOR). These data may promote DOR as a robust "HDL friendly" and "metabolism friendly", therapeutic agent that may attenuate morbidity in chronic treated HIV infection. Towards this aim, the investigators will study DOR-related effects on HDL (HDL-C levels and function) and ex vivo assays that determine key molecular determinants of atherogenesis.

NCT ID: NCT04819321 Not yet recruiting - Metabolic Disease Clinical Trials

Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI> 24.9 kg / m² and <30.0 kg / m²). The experimental design will consist of four assessments. In the first assessments a structured questionnaire will be applied to obtain health and food consumption data, in addition to evaluate anthropometric (weight, height, waist and hip circumference), and collection of blood. In addition, an ultrasound examination, digital photography and biopsy of the subcutaneous WAT, of the abdominal region, will be performed. After 30 day subjects will undergo CoolSculpting treatment(s) in an outpatient clinical setting. The treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage. Treatments will be administered according to the User Manual CoolSculpting System. The volunteers will return for the biopsy of the subcutaneous WAT, from the abdominal region, in 3 days after the procedure. In 4º assessment, 60 days after cryolipolysis, all evaluations performed in the first assessment will be repeated and to evaluate overall patient satisfaction for non-invasive fat reduction in CoolSculpting subjects.

NCT ID: NCT04814316 Recruiting - Clinical trials for Calcium Metabolism Disorders

Effects of Lansoprazole on Bone Turnover Markers

Start date: December 2, 2019
Phase:
Study type: Observational

Use of proton pump inhibitors (PPI) has increased in recent years. There are concerns that PPIs have possible negative effects on bone metabolism. It has been suggested that PPIs may reduce the absorption of calcium from the small intestine and lead to bone resorption by affecting osteoclastic activity. In this study, it is planned to investigate the effects of lansoprazole, a proton pump inhibitor, on bone turnover markers in pediatric patients with gastroesophageal reflux or gastroesophageal reflux disease.

NCT ID: NCT04812314 Recruiting - Obesity Clinical Trials

Exercise Effects on Adipose Tissue Structure and Function

LG
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.

NCT ID: NCT04809688 Not yet recruiting - Clinical trials for Nutritional and Metabolic Diseases

Saskatoon Berry on Metabolism and Gut Microbiota in Healthy Subjects

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Diabetes becomes epidemic in worldwide countries. Nine out of ten diabetic patients are type 2 diabetes (T2D). T2D is characterized by insulin resistance and obesity. Uncontrolled diabetes leads to serious consequences including heart attack, stroke, chronic renal failure, liver failure, blindness and low limb amputation. Most of hypoglycemic medications have side effects. Natural foods or nutraceuticals with hypoglycemic potential are expected to provide a safer management for diabetic patients. Saskatoon berry is a popular fruit in Canadian Prairie and Northern states in USA. Our recent studies demonstrated Saskatoon berry powder (SBp) attenuated hyperglycemia, hyperlipidemia, insulin resistance, inflammation, liver steatosis and gut dysbiosis in diet-induced insulin resistant mice, a model for T2D. The results in antidiabetic activities of SBp have been supported by other groups in high fat fed rats. The combination of findings suggest that Saskatoon berry is good candidate of prebiotic functional food as a supplemental remedy for reducing insulin resistance, metabolic syndrome and preventing or managing T2D. The effect of Saskatoon berry and its products on metabolic disorders have not been studied in human subjects. We propose to examine the effect of oral administration of freeze-dried Saskatoon berry on glucose metabolism, insulin resistance and gut microbiota in healthy adults in a pilot trial.

NCT ID: NCT04809220 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes

AWARD-JPN
Start date: April 13, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.

NCT ID: NCT04808817 Not yet recruiting - Cancer Clinical Trials

Relationship Between Immunity and Metabolism in Patients Receiving Immune Checkpoint Inhibitors for Advanced Cancer. ( RIMEC )

RIMEC
Start date: March 15, 2021
Phase: N/A
Study type: Interventional

Recent EMA and FDA approvals have made immune checkpoint inhibitors (ICI) a standard of care in cancer treatment. ICI, used alone or as a combination are now the backbone of renal cell and lung carcinoma treatment. However, a significant proportion of patients does not respond to ICI. Thus the identification of predictive response factor is a major issue. While factors associated with the tumour and its micro environment have been widely studied, factors associated with the patient such as metabolism could also affect the response to ICI and remain poorly studied. The hypothesis of the investigators is that dysmetabolims, via the induction of a chronic inflammatory state could induce a defect of lymphocyte production and activation as well as a modification of the immunogenicity of tumor cells and immune cells infiltration. The consequences could be a decrease in ICI response rate as well as an increase in immune related adverse events (irAEs). To test this hypothesis, the investigators propose a prospective bi-centric exploratory study including 60 patients treated with ICI for advanced lung or renal cell carcinoma. The data collected will be : - Clinical (calorimetry, impedancemetry, survey of eating habits, tumour characteristics, epidemiological data), - Biologics (baseline and 3-months plasma bio banking for standard biology, inflammation markers TNF- α, IL1-6-8-11-17, TGF-ß, TWEAK, complement study C3, C4, C4d, CH50, C1q, CD46) Primary objective is to assess the response to ICI depending on metabolic status. Secondary objectives are to study the relationships between metabolism / cytokines profile/ complement profile and ICI response. The investigators seek to generate hypotheses and to obtain exploratory data before submission of a Hospital Clinical Research Program whose objective will be to evaluate the impact of dysmetabolism on overall survival and to characterize immune and anatomopathological profiles (using DNA microarrays and flow cytometry techinques) of patients treated with ICI for renal cell or lung carcinoma.

NCT ID: NCT04807959 Completed - Obesity Clinical Trials

Evaluation of the Effectiveness of a Comprehensive Visceral Adiposity-Focused Anti-Obesity Program

Start date: October 27, 2016
Phase:
Study type: Observational

A retrospective review of body composition outcomes of participants of a comprehensive visceral-fat focused anti-obesity program. Data from approximately 2000-2500 participants are expected to be included in the study.

NCT ID: NCT04804319 Not yet recruiting - Metabolic Disease Clinical Trials

Interactions Between Diet, Microbiome and Abiotic Conditions in the Gut

PRIMA
Start date: April 1, 2021
Phase:
Study type: Observational

The aim of this study is to explore the interplay between environmental (abiotic) factors in the gut and the gut microbiota composition, diversity and metabolism. Such insights could help us understand personal responses to diets and be a first step towards personalized dietary recommendations targeting the gut microbiome.