Diabetes Trials Overview

Search for recent trials on diabetes

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I found recent clinical trials on diabetes, highlighting diverse research interests and locations. Here are summaries of three trials:

1. Probiotic Supplementation for Maternal Depression in Gestational Diabetes

   • Trial ID: ISRCTN96215615
   • Location: Turkey
   • Sponsor: Eastern Mediterranean University
   • Overview: This interventional trial explores the effect of probiotic supplementation on maternal depression, anxiety, and attachment in gestational diabetes by improving the Mediterranean diet quality. It aims to enroll 64 female participants. The study does not specify the intervention names but focuses on quality of life and treatment【source†source】.

2. GLY-200 for Duodenal Exclusion (GLYDE Study)

   • Trial ID: 387051
   • Sponsor: The University of Adelaide
   • Status: Not yet recruiting
   • Overview: This Phase 2 interventional trial investigates the effects of GLY-200 on plasma glucose concentrations, gastric emptying, small intestinal transit, glucose absorption, and insulin and gut hormones after a high carbohydrate semi-solid meal in healthy humans and people with uncomplicated type 2 diabetes. It plans to enroll 32 participants of all genders【source†source】.

3. Direct Versus Indirect Effect of Amino Acids on Hepatokines

   • Trial ID: NCT06240039
   • Location: Denmark
   • Sponsor: University of Copenhagen
   • Status: Not yet recruiting (Last update: 2024-02-02)
   • Overview: This interventional study examines the direct versus indirect effect of amino acids on hepatokines in healthy subjects and patients with non-alcoholic fatty liver disease and obesity. The trial will evaluate the acute effect of an amino acid infusion with and without a concomitant infusion of the somatostatin analogue octreotide to eliminate endogenous production of glucagon. It aims to enroll 30 adult participants【source†source】.

These trials illustrate the broad scope of diabetes-related research, from dietary interventions to novel treatments for related conditions. If you need more detailed information on any of these studies or wish to explore more trials, please let me know.

tell me more detailed information of the second trial

The GLY-200 for Duodenal Exclusion (GLYDE Study) is a phase 2 interventional trial designed to investigate the effects of GLY-200 on plasma glucose concentrations, gastric emptying, small intestinal transit, glucose absorption, and insulin and gut hormones after a high carbohydrate semi-solid meal in both healthy humans and individuals with uncomplicated type 2 diabetes treated only with diet or metformin. Here are detailed aspects of the study:

Description

GLY-200 is an orally-administered, pH-dependent, gut-restricted therapeutic polymer developed by Glyscend Therapeutics. It interacts with the mucus on the surface of the duodenum to form a temporary barrier, mimicking the effects of gastric bypass surgery by excluding the duodenum from contact with meal contents. The study aims to explore the mechanisms behind the duodenum's exclusion in reducing blood glucose levels and body weight, which may involve altering the stomach's emptying rate, small intestine content passage, glucose absorption, or hormonal levels.

Eligibility Criteria

• Healthy Volunteers:

  • Males and females aged 40 to 79
  • BMI between 19 to 32 kg/m^2
  • HbA1c less than 5.7%
  • Fasting blood glucose less than 5.6 mmol/L

• Type 2 Diabetes (T2D) Patients:

  • Diagnosed with T2D
  • Aged 40 to 79 years
  • BMI from 20 to 40 kg/m^2
  • HbA1c less than 8.5% on stable treatment with diet and/or metformin

Exclusion Criteria

Excludes individuals using medications that influence gastrointestinal function, body weight, or appetite, those with a history of gastrointestinal diseases or significant surgeries, heart disease, other significant illnesses, impaired renal or liver function, recent participation in other studies, exposure to ionising radiation, and pregnant or lactating women.

Study Design

This randomized, double-blind, crossover assignment trial involves two treatment periods of 7 days each, separated by an interval of at least 14 days. Treatments consist of GLY-200 or a placebo, administered twice daily. Participants will keep a daily record of gastrointestinal symptoms and stool frequency and form, and undergo scintigraphic imaging and blood sampling to evaluate the treatment's effects.

Intervention Details

Participants will be given GLY-200 2.0 g or placebo in gelatin capsules twice daily before meals. The study includes detailed monitoring of gastrointestinal symptoms, appetite perceptions, heart rate, blood pressure, and energy intake from a buffet meal provided at the study's end.

Objective

The objective is to understand how duodenal exclusion impacts blood glucose levels and body weight through various physiological mechanisms, potentially offering insights into non-surgical treatments for diabetes and obesity.

The trial, sponsored by The University of Adelaide with collaboration from Glyscend Therapeutics, is anticipated to start on April 1, 2024, with an expected completion date of February 2, 2026. This study represents a significant step in exploring innovative treatments for type 2 diabetes and obesity through non-surgical means.

continue

Continuing from the previous details, the GLY-200 for Duodenal Exclusion (GLYDE Study) aims to provide significant insights into the treatment of type 2 diabetes and obesity. The study's innovative approach, which simulates the effects of gastric bypass surgery without the need for an actual surgical procedure, could potentially offer a new therapeutic pathway for patients struggling with these conditions.

Key Aspects of the Study

• Secondary Outcomes: The study will measure differences in postprandial blood pressure and heart rate between study days after GLY-200 and placebo treatment. These measurements will be taken at various time points on the last day of each treatment period to evaluate the treatment's impact on cardiovascular responses to meals.

• Inclusion of Healthy Volunteers and T2D Patients: By including both healthy volunteers and individuals with type 2 diabetes, the study aims to assess the effects of GLY-200 across a spectrum of glucose tolerance, from normal to impaired. This will help understand whether the mechanism of action of GLY-200 is effective in both preventive and therapeutic contexts.

• Detailed Intervention Protocols: The study's intervention protocol, including a double-blind, crossover design, ensures that each participant acts as their own control, increasing the reliability of the results. The detailed protocol for meal consumption, fasting, and monitoring before and after treatment periods is designed to closely monitor the physiological effects of the intervention.

• Study Duration and Design: With an anticipated start date in April 2024 and completion by February 2026, the study's timeline allows for thorough data collection and analysis. Its design focuses on understanding the temporary barrier formed by GLY-200 on the duodenum's surface and its implications for diabetes and obesity treatment.

Potential Impact

The GLYDE Study's outcomes could significantly impact our understanding and management of type 2 diabetes and obesity. By exploring non-surgical methods to mimic the benefits of gastric bypass surgery, this research could lead to more accessible and less invasive treatment options for patients. Additionally, it could provide valuable insights into the role of the duodenum in metabolic regulation and the potential therapeutic targets within the gastrointestinal tract for metabolic diseases.

Conclusion

The GLY-200 for Duodenal Exclusion (GLYDE Study) represents an exciting avenue of research in the field of metabolic diseases. Its innovative approach to simulating the effects of gastric bypass surgery without the associated risks and complications could pave the way for new treatments. As the study progresses, it will be crucial to monitor its findings for their potential to offer safer, effective treatment alternatives for individuals with type 2 diabetes and obesity.

are there any similar trials?

To find similar trials to the GLY-200 for Duodenal Exclusion (GLYDE Study), I can search for trials that are relevant to the themes of diabetes management, obesity treatment, or interventions that mimic the effects of gastric bypass surgery without the need for actual surgery. However, since the detailed information response doesn't provide '_id' or 'cbr' (Clinical Trial Relevance Score) directly, I can't automatically pull similar trials based on those specific identifiers.

Given the uniqueness of the GLY-200 study's approach, similar trials might focus on metabolic interventions, non-surgical treatments for diabetes and obesity, or other innovative therapies aimed at mimicking the beneficial effects of bariatric surgery on metabolic health.

Would you like me to perform a general search for trials related to non-surgical diabetes and obesity treatments, or do you have a specific aspect of the GLY-200 study you're interested in exploring further?