Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Chromium & Isomaltulose drink with added electrolytes: 1 L (divided in 5 equal parts),
Oral, Day 1 of Period 1/2/3
Control Intervention1: Chromium & Sucrose drink with added electr
Sponsors
Johnson & Johnson Pte Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Healthy Adult Population 1. Participant has signed and dated informed consent document before participating in any study-specific procedures, indicating the participant has been informed of all pertinent aspects of the study. 2. Participant is able to read and understand the local language. 3. Adults with age range of 18 to 30 years. 4. Healthy adults with no known interfering/limiting conditions as judged by the PI based on detailed Medical History 5. Participants with Body Mass Index: BMI 18.5 22.9 kg/m2. 6. Participants with USG less than or equal to 1.025 (at arrival of each testing period). 7. The participant should refrain from tobacco and caffeine usage for at least 12 hours, from consuming alcohol and from participating in strenuous physical activity for at least 24 hours prior to each experimental period. 8. The participant is able to comprehend the requirements of the study (based upon clinical site personnel s assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified within the protocol. Patients with T2DM 1. Participant has signed and dated informed consent document before participating in any study-specific procedures, indicating the participant has been informed of all pertinent aspects of the study. 2. Participant is able to read and understand the local language. 3. Adults with age range of 18 to 60 years. 4. Diagnosed with T2DM for more than or equal to 12 weeks; treated with metformin with or without sulfonylureas at a stable dose for more than or equal to 12 weeks. 5. Participants with Body Mass Index: BMI 18.5 less than 35 kg/m2. 6. Participant with USG less than or equal to 1.025 (at arrival of each testing period). 7. Participant with HbA1c of 6.5percent 9percent. 8. The participant refrained from tobacco and caffeine usage for at least 12 hours, from consuming alcohol and from participating in strenuous physical activity for at least 24 hours prior to each experimental period. 9. The participant is able to comprehend the requirements of the study (based upon clinical site personnel s assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified within the protocol. 10. Patients with T2DM who does not have comorbidities or who have co-existing stable conditions commonly seen in this population, as listed below: o Fairly-controlled hypertension (e.g., BP less than 150/100 mmHg with or without medication). o History of early-stage diabetic nephropathy (e.g., estimated glomerular filtration rate: eGFR more than 60 mL/min/1.73m ) a. o Stable cardiovascular disease (e.g. more than 6 months post-MI, no recent angina or congestive heart failure: CHF exacerbations).
Exclusion criteria
Exclusion criteria: Healthy Adult Population 1. Participants with any history of diabetes or impaired glucose tolerance. 2. Female participants who are pregnant or breastfeeding or planning to become pregnant. 3. Females in perimenopausal state (before becoming amenorrhoeic for at least 12 consecutive months). 4. Participants with any prescribed medications at the time of inclusion that may interfere with carbohydrate metabolism and fluid balance, e.g., diuretics, cyclosporin, steroids or any other treatments that cannot be allowed in the study, in the opinion of the investigator. 5. Known sensitivity to the investigational product(s) and its ingredients. 6. Participants who are participating in a clinical trial and/or treated with any investigational product within 3 months preceding the first intake of study Investigational Product. 7. Participants with clinically significant medical conditions that are unstable or uncontrolled and may interfere with a participant participation in the study in the opinion of the medically qualified investigator. 8. Participants are following prolonged fasting or intermittent fasting (e.g., fasting periods exceeding 12-16 hours regularly). 9. Participant is related to persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other study personnel, employees of Kenvue subsidiaries, contractors of Kenvue, and the families of each). 10. Participants who have other severe, acute or chronic, medical condition(s) (e.g., CVD, renal disease, UTI), laboratory abnormality(ies), or history of gastrointestinal surgery(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the medically qualified investigator, would make the participant inappropriate for entry into this study. Patients with T2DM 1. Females who are pregnant or breastfeeding, or planning to become pregnant. 2. Females in perimenopausal state (before becoming amenorrhoeic for at least 12 consecutive months). 3. Adults on prescribed medication at the time of inclusion that may interfere with carbohydrate metabolism, (other than metformin with or without sulfonyl ureas) and fluid balance, e.g. cyclosporin, or any other treatments that cannot be allowed in the study, in the opinion of the investigator. 4. Adults on prescribed medications at the time of inclusion like Steroids, SGLT2 inhibitors, GLP-1 agonists, diuretics, alpha-glucosidase inhibitor, and drugs that affect hydration status. 5. Known sensitivity to the investigational product(s) and its ingredients. 6. Participants who are participating in a clinical trial and/or treated with any investigational product within 3 months preceding the first intake of study Investigational Product. 7. Participants with clinically significant medical conditions that are unstable or uncontrolled and may interfere with a participation of the participant in the study in the opinion of the medically qualified investigator. 8. Participants with following conditions will be excluded: o Known to have hepatic impairment - Known cirrhosis or ALT/AST more than 3 times ULN.b o Type-1 diabetes mellitus or latent autoimmune diabetes in adults (LADA).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healthy Adult Population Difference between the BHI of electrolyte beverage containing isomaltulose with that of the electrolyte beverage containing sucrose Patients with T2DM Difference between the BHI of electrolyte beverage containing isomaltulose with that of the electrolyte beverage containing sucroseTimepoint: Healthy Adult Population Post 2 hours of beverage consumption. Patients with T2DM Post 2 hours of beverage consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| Healthy Adult Population and Patients with T2DM a) Difference between the BHI of electrolyte beverage containing isomaltulose with that of the electrolyte beverage containing sucrose b) Difference between the BHI of electrolyte beverage containing isomaltulose with that of the water c) Difference between the BHI of electrolyte beverage containing isomaltulose with that of the water d) Difference in blood glucose levels between beverages following consumption of fluids e) Difference in plasma insulin levels between beverages following consumption of fluids f) Difference in plasma lactate levels between beverages following consumption of fluids g) Difference in net fluid balance between beverages following consumption of fluidsTimepoint: Healthy Adult Population and Patients with T2DM a) Post 4 hours of beverage consumption b) Post 2 hours of beverage consumption c) Post 4 hours of beverage consumption d) Baseline, and for every 30 min upto 4 hours post beverage consumption e) Baseline, and for every 30 min upto 4 hours post beverage consumption f) Baseline, and for every 30 min upto 4 hours post beverage consumption g) Baseline, and for every 30 min upto 4 hours post beverage consumption | — |
Countries
India
Contacts
Public ContactDivya Purusothaman
Kenvue
Outcome results
None listed