Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05423938
Other study ID # DIACARE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2019
Est. completion date February 17, 2022

Study information

Verified date June 2022
Source Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rationale: The aim of the study was to compare the glycemic and insulinemic response of malnourished patients with type 2 diabetes after oral feed between a diabetic oral nutritional supplements (ONS) and a standard one. Methods: Randomized, double-blind, crossover, multicenter clinical trial, conducted in patients with type 2 diabetes and a diagnosis of malnutrition (SGA). Patients were randomized to receive two ONS: diabetic (Bi1 diacare hp/hc) or control (standard, isocaloric and isoproteic), a week apart. A glycemia and insulinemia curve was made at times: 0', 30', 60', 90', 120', and 180', after drank 200 ml of the ONS. The analyzed variables were the area under the curve (AUC 0-t) of glucosa and insulin, and the maximum concentration of glucose (Cmax).


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date February 17, 2022
Est. primary completion date February 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Diagnosed with DM2 (confirmed by the use of oral hypoglycemic agents for at least two months). - Patients at nutritional risk diagnosed through the Subjective Global Assessment. - Adequate cultural level and understanding of the clinical study. - Agree to voluntarily participate in the study and give their informed consent in writing. - Non-pregnant and non-lactating women or women who have given birth at least six weeks prior to the screening visit. Exclusion Criteria: 1. Type 1 DM, DM2 with insulin treatment and DM secondary to steroids. 2. Consumption of alpha-glucosidase inhibitors. 3. Current infection (requiring medication or hospitalization), patients undergoing inpatient surgery, or receiving corticosteroids within the past three months or antibiotics within the past three weeks prior to Screening Visit. 4. BMI > 35 Kg/m2. 5. Active malignant neoplasm (except the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in situ of the cervix uteri). 6. End-stage organ failure (such as end-stage renal disease) or organ transplant. 7. Advanced chronic kidney disease (glomerular filtration rate < 30 ml/min). 8. Severe liver disease. 9. Severe gastroparesis. 10. Chronic infectious disease, such as active tuberculosis, hepatitis B or C, or HIV infection. 11. Consumption of phytotherapy products, dietary supplements or medications except oral hypoglycemic agents, during the four weeks prior to the screening visit, which could profoundly affect (in the opinion of the PI) blood glucose. 12. Allergy or intolerance to any component of the products under study. 13. Participation in a concurrent trial that conflicts with this study.

Study Design


Intervention

Dietary Supplement:
Diabetic
It is a hypercaloric and hyperproteic dietary supplement formulated to contribute to control the glycemia with: a specific mix of carbohydrate with a low GI, fiber, EVOO and EPA&DHA
Control
It is a hypercaloric and hyperproteic dietary supplement formulated without the ingredients to contribute in the glycemia control

Locations

Country Name City State
Spain José M. García Almeida Málaga

Sponsors (2)

Lead Sponsor Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Adventia Pharma

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postprandial glycemic response 180 minutes
Secondary Postprandial insulin response 180 minutes
See also
  Status Clinical Trial Phase
Completed NCT05219994 - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum N/A
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Completed NCT02284893 - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone Phase 3
Completed NCT04274660 - Evaluation of Diabetes and WELLbeing Programme N/A
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Active, not recruiting NCT05566847 - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed NCT04965506 - A Study of IBI362 in Chinese Patients With Type 2 Diabetes Phase 2
Recruiting NCT06115265 - Ketogenic Diet and Diabetes Demonstration Project N/A
Active, not recruiting NCT03982381 - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes Phase 4
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Completed NCT04023539 - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed NCT03960424 - Diabetes Management Program for Hispanic/Latino N/A
Completed NCT04097600 - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets Phase 1
Completed NCT05378282 - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Active, not recruiting NCT06010004 - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Phase 3
Completed NCT03653091 - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes N/A