Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L) Clinical Trial
Official title:
Fresh Pomegranate Juice Decreases Fasting Serum Erythropoietin in Patients With Type 2 Diabetes
| NCT number | NCT03902288 |
| Other study ID # | IRB-20120189 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2012 |
| Est. completion date | April 2013 |
| Verified date | April 2019 |
| Source | Jordan University of Science and Technology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Fresh pomegranate juice at 1.5 mL/kg of body weight was administered by recruited healthy
individuals and patients with type 2 diabetes of fasting serum glucose between 7.1 and 15.8
mmol/L after approximately 12 hours fasting. Blood samples were collected in plain tubes
before (-5 minutes) and at 1 and 3 hours after drinking pomegranate juice. Blood samples were
centrifuged and serum was collected and stored for glucose and hormonal analysis. Patients
were recruited from those of earlier stages of type 2 diabetes, and many of them already
drink pomegranate juice as of its benefits for their health).
The exclusion criteria included subjects with renal or hepatic disease, pregnancy, treatment
with insulin, and hormone therapies. Participants who had either smoked cigarettes or taken
antioxidant supplements, lipid-lowering drugs, and oral hypoglycemic agents, such as
metformin (glucophage) or sulfonylureas, within the preceding 12 hours were also excluded.
The study was explained to all of the recruited subjects by the clinical researchers, and
written informed consent was obtained prior to enrollment. Approval for the study was
provided by the IRB Committee at Jordan University of Science and Technology (Irbid, Jordan).
| Status | Completed |
| Enrollment | 85 |
| Est. completion date | April 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 35 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Patients with type 2 diabetes at early stages of progression (Fasting serum glucose: 7.1 - 15.8 mmol/L) - Healthy individuals (Fasting serum glucose < 7 mmol/L) Exclusion Criteria: - Subjects with renal - Subjects with hepatic disease - Pregnant women - Subjects under treatment with insulin and any other hormonal therapies - Smoking 12 hours before the intervention - Antioxidant supplements 12 hours before the intervention - Drugs administration: Lipid lowering drugs, oral hypoglycemic agents such as metformin or sulfonylureas 12 hours before the intervention. |
| Country | Name | City | State |
|---|---|---|---|
| Jordan | Jordan University of Science and Technology | Irbid |
| Lead Sponsor | Collaborator |
|---|---|
| Jordan University of Science and Technology |
Jordan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Fasting serum glucose measurement | Measuring the alteration in fasting serum glucose in mmol/L before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | |
| Primary | Insulin hormone measurement | Measuring insulin in µIU/mL before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | |
| Primary | Erythropoietin hormone measurement | Measuring erythropoietin in mIU/mL before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | |
| Primary | Thyroxine hormone measurement | Measuring erythropoietin in µg/dL before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | |
| Primary | Cortisol hormone measurement | Measuring erythropoietin in nmol/L before and at 1 and 3 hours following pomegranate juice ingestion | 1 -3 hours | |
| Secondary | Melatonin hormone measurement | Measuring Melatonin in pg/mL before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | |
| Secondary | Testosterone hormone measurement | Measuring testosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | |
| Secondary | Aldosterone hormone measurement | Measuring aldosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | |
| Secondary | Serum total antioxidant activity measurement | Measuring serum total antioxidant activity in Trolox equivalents before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours |