Moringa in Diabetes

Phase 1

• Conditions: Diabetes mellitus type 2; Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

• Registration Number: RPCEC00000395
• Lead Sponsor: Research Center for Protein Plants and Bionatural Products

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-02
• Study Completion: 2022-12-30
• Results First Posted: 2023-01-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Patients who meet the diagnostic criteria.
2. Adults 19-75 years
3. Initial HbA1c =7% = 9%
4. Patients who have given their informed consent to participate in the study.

Exclusion Criteria

1. Patients who, before starting the study, present elevations of: glutamic oxaloacetic transaminase, glutamic pyruvic transaminase, total bilirubin, or alkaline phosphatase greater than or equal to 2.5 times the institutional upper normal limit.
2. Patients who, before starting the study, present a glomerular filtration rate of less than 60 ml / min according to the Cockcroft-Gault formula.
3. Patients treated with steroids by any route of administration 3 months before starting the study.
4. Patients with unstable ischemic heart disease or decompensated arterial hypertension.
5. Patients being treated with insulin or another hypoglycemic agent other than Metformin.
6. Patients with decompensated diabetic complications that require treatment.
7. Anticoagulated patients or those with blood dyscrasias and hemolytic anemia.
8. Pregnant and postpartum and breastfeeding patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation of glycosylated hemoglobin values (difference of the baseline Hb1Ac value with respect to the final value). Measurement time: At baseline and, at 4 months.