CTRI/2024/04/066499已完成4 期
A randomized, double-blind, placebo-controlled, parallel clinical study to determine the safety and tolerability of a range of doses of PeptiControl in pre-diabetic individuals.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- To investigate the tolerability of a range of doses of PeptiControl™ as assessed by occurrence of hypoglycemic episodes evaluated by time below target range (70 – 180 mg/dL) during Continuous Glucose Monitoring (CGM) throughout the intervention.
研究概览
简要总结
The present study is a randomized, double-blind, placebo-controlled, parallel clinical study. 208 participants will be screened, and considering a screen failure rate of 40%, 124 participants will be randomized in a ratio of 1:1:1:1 to either of the 4 arms:
Arm 1 (Low – dose) – PeptiControl™
Arm 2 (Mid – dose) – PeptiControl™
Arm 3 (High – dose) – PeptiControl™
Arm 4 (Placebo) – Placebo
The participants will be assigned a unique randomization code. Each arm will have at least 25 completed participants after accounting for a dropout/withdrawal rate of 20%. The intervention duration for all the study participants is 6 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and Females (30-60 years of age)
- •Individuals with Body Mass Index (BMI) more than or equal to 25 and less than or equal to 33.0 kg/m²
- •Individuals with fasting blood glucose (FBG) more than or equal to 100 mg/dL and less than or equal to 125 mg/dL after 8-10 hours fasting.
- •Individual must be a non-smoker or an ex-smoker (5 years or more).
- •Have a stable body weight (less than or equal to 4.5 kgs change) in the last 3 months (as self-reported by the individual).
- •Be willing to maintain existing dietary habits and physical activity levels throughout the study period.
- •Individuals who have given their signed Informed Consent.
排除标准
- •Individuals having fasting blood glucose levels less than 100 mg/dL or more than 125 mg/dL.
- •Individuals having BMI outside the range of
- •33 kg/m².
- •Individuals who are presently dieting, or who were using medications affecting body weight or who had experienced a change in weight of more than 4.5 kg or a change in physical activity within the six months preceding the screening visit.
- •Individuals diagnosed with Type I Diabetes mellitus.
- •Individuals diagnosed with Type II Diabetes mellitus and currently on medication.
- •Individuals with Triglyceride levels more than 200 mg/dL, and/or liver function tests (AST, ALT) levels 1.5 times than the normal range, and/or kidney function test (serum creatinine) levels 1.5 times than the normal range.
- •Individuals with low haemoglobin or haematocrit (i.e., lower than normal ranges [less than 12.0 g/dL hemoglobin levels in women and less than 13.0 g/dL hemoglobin levels in men])
- •Individuals having a significant acute or chronic co-existing illness such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrine disorder, immunological disorder, metabolic disease, or any condition which contraindicates, in the investigator’s judgement, entry to the study or which poses a significant risk to the individual.
- •Individuals diagnosed with hypertension (systolic blood pressure more than 140 mm Hg and/or diastolic blood pressure more than 90 mm Hg) and currently on medication.
- •Individuals who have unstable medical conditions or who are on chronic medication that has not been at a stable dose for at least 1 month.
- •Consumption of more than the recommended alcohol guidelines i.e., more than 21 alcohol units/week for males and more than 14 alcohol units/week for females.
- •Currently or recently (within 3 months of study entry) taking any medication, which in the opinion of the investigator, could interfere with the outcome of the study, including insulin, acetylsalicylic acid, thyroxine, beta blockers, or hypolipidemic agents.
- •Individuals on any medications associated with weight loss such as medication for the treatment of deficit hyperactivity, medication associated with weight gain like antipsychotics, or glucocorticoids, and/or immunosuppressants.
- •Have a known allergy or sensitivity to any compounds in the test material’s active or inactive ingredients or placebo.
- •Individuals having a history of drug or alcohol abuse.
- •Individuals who have a history of neurological disorders or significant psychiatric illness, who are cognitively impaired and/or who are unable to give informed consent.
- •Present or recent use (within 3 months of pre-screening) of dietary supplements that may affect the level of blood glucose, e.g., chromium, dietary fibres, and non-digestible carbohydrates e.g., fructo-oligosaccharides chicory inulin, mulberry leaf extract.
- •Females who are pregnant, lactating or wish to become pregnant during the study.
- •Individuals with evidence of a clinically unstable disease (such as depression), as determined by medical history, physical examination, that, in the Investigator and medical monitors opinion, preclude entry into the study.
- •Breast feeding women.
- •Immune compromised individuals.
- •Individuals who have participated in a clinical study with an investigational product (IP) within 90 days before pre-screening, or who plan to participate in another study during the study period.
结局指标
主要结局
To investigate the tolerability of a range of doses of PeptiControl™ as assessed by occurrence of hypoglycemic episodes evaluated by time below target range (70 – 180 mg/dL) during Continuous Glucose Monitoring (CGM) throughout the intervention.
时间窗: Day 0 to Day 10
次要结局
- To explore the safety of a range of doses of PeptiControlâ„¢ as assessed by the safety blood panel.(Day 0 and Day 6)
- To assess the efficacy of range of doses of PeptiControlâ„¢ given 30 minutes prior to OGTT as compared to placebo on Glucose Management as assessed by OGTT(At 0, 15, 30, 60, 90, 120 and 180 minutes on day 0)
- To assess the efficacy of range of doses of PeptiControlâ„¢ given 30 minutes prior to OGTT as compared to placebo on Glucose metabolism as assessed by incremental Area Under Curve (iAUC) blood glucose(At 0, 15, 30, 60, 90, 120 and 180 minutes on day 0)
- To assess the efficacy of range of doses of PeptiControlâ„¢ as compared to baseline & placebo on Pancreatic efficiency as assessed by fasting serum insulin(Day 0 and Day 6)
- To assess the efficacy of range of doses of PeptiControlâ„¢ as compared to baseline & placebo on Time in range via CGM starting from day -2(Starting from day -2 and worn continuously until day 10 with readings taken at day -2, day 0, day 6, day 10)
- To assess the efficacy of range of doses of PeptiControlâ„¢ as compared to baseline & placebo on Insulin sensitivity as assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(Day 0 and Day 6)
- To assess the efficacy of range of doses of PeptiControlâ„¢ as compared to baseline & placebo on Working memory as assessed by Paired Associate Learning test.(Day 0, Day 6, and Day 10)
- To assess the efficacy of range of doses of PeptiControlâ„¢ as compared to baseline & placebo on Selective attention as assessed by Stroop test.(Day 0, Day 6, and Day 10)
- To assess the efficacy of range of doses of PeptiControlâ„¢ as compared to baseline & placebo on Hunger, satiety and fullness as assessed by the Visual Analog Scale (VAS)(Day 0, Day 6, and Day 10)
研究者
Dr Shalini Srivastava
Vedic Lifesciences Pvt. Ltd.
研究点 (8)
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