跳至主要内容
临床试验/CTRI/2025/01/079161
CTRI/2025/01/079161进行中(未招募)2 期

A randomized, double blind, parallel, placebo-controlled study to evaluate metabolic health and gut microbiome in presence of GlucoSEB PB in diabetic adults as integrative care.

Advanced Enzymes Technologies Ltd.1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月3日最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
90
试验地点
1
主要终点
Change in HbA1c (assessment on Day -1 to Day -7, Day 90 and Day 180)

研究概览

简要总结

T2DM can be a long-term condition that requires extended blood sugar management: the combined approaches such as pharmacological, physical and, in recent years, therapeutic interventions directed at the microbiome are the most effective in managing it (Diagnosis and Classification of Diabetes Mellitus, 2013). While standard formulations which include insulin, metformin and SGLT2 inhibitors assist patients to manage their blood glucose levels, they rarely come without a fair share of side effects such as hypoglycemia, weight gain or gastrointestinal problems (Wilcox et al., 2020). They do not, however, resolve the underlying problems that lead to insulin resistance and β-cell dysfunction. For this reason, there has been a growing need to look for new and safer, and combined therapies that help not only control hyperglycemia but also treat underlying conditions, the imbalanced metabolic state (Cerf, 2013).The enzyme blend GlucoSEB PB can be a part of diabetic care regimen. The enzymes modulate carbohydrate metabolism while probiotics support in improving gut health. Numerous studies have reported that the gut microflora is closely related to body metabolism. An imbalance of intestinal microbiota, or dysbiosis, is one characteristic of T2DM that leads to metabolic dysregulation by causing insulin resistance, systemic inflammation and increased gut permeability (Hou et al., 2022; Wu et al., 2023; Xia et al., 2021). GlucoSEB PB consists of components that have gut microbiome targeted mechanisms primarily focused on enhancing metabolic parameters in patients with diabetes rather than solely targeting dysglycemia. The aim of evaluating GlucoSEB PB is described as follows:  Metabolic Health: The enzyme blend is useful in decreasing the glycemic index of consumed carbohydrates by controlling the free glucose into the bloodstream, thus lowering blood glucose levels after a meal. This might have special significance in avoiding glucose toxicity which is one of the factors that lead to insulin resistance. The manufacture of prebiotic fibers also helps in metabolic health by altering the gut microbiota which may increase insulin sensitivity and decrease systemic inflammation levels.  Gut Microbiome Modulation: Since there is a wealth of data associating gut dysbiosis and T2DM; promoting good gut bacteria through GlucoSEB PB is of particular interest. There are studies that support the use of Probiotics as adjunct therapy for blood sugar control and those that reduce inflammation and improve metabolic disease. Since GlucoSEB PB may promote a healthier microbiome, it may also have a wider effect on metabolic health other than dysglycemia. GlucoSEB PB treatment combines the benefits of targeting metabolic and gut health to diminish the ill effects caused due to diabetes. GlucoSEB PB is an advanced therapy that promises new avenues aimed at diabetes management.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Subjects with less physical activity
  • BMI 18.5 to 35 Kg/m2
  • Subjects with recent HbA1c reports within 2 weeks can be considered as screening value for participation in the study.
  • Subjects taking stable medicine dose for past 3 months
  • Subjects who occasionally consume sweets
  • Subjects with fasting blood sugar level ≥130 mg/dL and HbA1c 7.0 to 11.0%
  • Subjects must have a history of diabetes for more than 1 year and have been on a stable medication regimen for at least the past 9 months
  • Subjects willing to give written informed consent and adhere to all the requirements of this protocol.

排除标准

  • Pregnant and lactating female.
  • Subjects with BMI greater than or equal to 35
  • Type I diabetic patients
  • HbA1c less than 7.0 and greater than 11.0%
  • Diabetes medication (DPP4 inhibitors, Acarbose, Voglibose, Repaglinide, GLP1 receptor agonists (GLP1RA), and Insulin)
  • Patients with major chronic complications (including but not limited to) autoimmune disease, inflammation, etc.
  • Organic insufficiency (cardiac, hepatic, renal, respiratory)
  • Use of food supplements specifically containing fibers or polysaccharides
  • Chronic smoking and alcohol intake
  • Allergy to the ingredients in the test product.
  • History of any surgery in the past 3 months.
  • Subject currently taking or has in the past 30 days used GI related probiotics or prebiotics or any enzymes [prescription or over the counter (OTC)].

结局指标

主要结局

Change in HbA1c (assessment on Day -1 to Day -7, Day 90 and Day 180)

时间窗: 180 days

次要结局

  • 1. Change in fasting blood glucose (assessment on Day -1 to Day -7, Day 90 & Day 180).(2. Change in fasting insulin (assessment on Day 1, Day 90 & Day 180))
  • 5. Change in anthropometric parameters (assessment on Day -1 to Day -7, Day 1, Day 90 & Day 180) - Body mass index (BMI), Waist circumference (WC), Waist-to-hip ratio (WHR), Body fat percentage((BFP).)
  • 10. CBC analysis on Day 1, Day 90 & Day 180, & vital sign measurement (assessment on every visit).(11. Monitoring subjects for any side effects occurred during the treatment. (weekly follow up- telephonic or)

研究者

发起方
Advanced Enzymes Technologies Ltd.
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Harsha Pamnani

Dr Harsha Pamnani

研究点 (1)

Loading locations...

相似试验