## Protocol Section
### Identification Module
**NCT ID:** NCT06423729

**Brief Title:** Effect of Nicorandil in Type 2 Diabetic Obese Patients

**Official Title:** Clinical Study Evaluating the Effect of Nicorandil in Type 2 Diabetic Obese Patients Treated With Sulfonylurea

#### Organization Study ID Info
**ID:** Nicorandil in DM
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tanta University

#### Responsible Party

**Investigator Affiliation:** Tanta University

**Investigator Full Name:** Merna Mohamed Seddik Ali

**Investigator Title:** Merna Mohamed Seddik Ali , Master degree in Clinical Pharmacy, Tanta University

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 1. Evaluating the effect of nicorandil on glycemic control of diabetic obese patients treated with sulfonylureas.
2. Investigating the effect of nicorandil on body weight of diabetic obese patients treated with sulfonylureas.

### Conditions Module

**Conditions:**

- Diabetes Mellitus, Type 2

**Keywords:**

- Type 2 DM, Nicorandil, Obesity

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 46

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 23 patients who will receive 2nd generation sulfonylureas only, for three months.

**Label:** Control Arm

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** 23 patients who will receive a combination of 2nd generation sulfonylureas and nicorandil 10 mg twice daily,for three months.

**Intervention Names:**

- Drug: Nicorandil 10 MG

**Label:** Nicorandil Arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Nicorandil Arm

**Description:** Patients will receive oral Nicorandil 10 MG twice daily in addition to 2nd generation sulfonylureas , for 3 months.

**Name:** Nicorandil 10 MG

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Change in HbA1c (From baseline to 12 weeks)

**Measure:** Change in HbA1c level

**Time Frame:** The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

**Description:** Change in body weight (From baseline to 12 weeks).

**Measure:** Change in body weight.

**Time Frame:** The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

**Description:** Change in Body mass index (BMI) (From baseline to 12 weeks).

**Measure:** Change in Body mass index (BMI)

**Time Frame:** The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

**Description:** Change in Visceral adiposity index (VAI) (From baseline to 12 weeks).

**Measure:** Change in Visceral adiposity index (VAI).

**Time Frame:** The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

#### Secondary Outcomes

**Description:** Assessment of Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide levels by ELISA Kits according to manufacturer's instructions.

**Measure:** Change in Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide (NO) serum levels.

**Time Frame:** The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diabetes duration ranged from 1 to 10 years.
* Body mass index (BMI) \>30 Kg/m2.
* The selected patients are treated with sulfonylureas alone.
* The age of selected patient ranged from 18 and 60 years.

Exclusion Criteria:

* Pregnant and lactating females.
* Patients with hypersensitivity to nicorandil.
* Uncontrolled hypertension and its antihypertensive medications
* Severe renal or hepatic disease.

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** merna198ali@gmail.com

**Name:** Merna Mohamed Seddik Ali

**Phone:** +201026064628

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tanta

**Contacts:**

***Contact 1:***

- **Email:** merna198ali@gmail.com

- **Name:** Merna Mohamed Seddik Ali, Master degree

- **Phone:** +201026064628

- **Role:** CONTACT

***Contact 2:***

- **Name:** Merna Mohamed Seddik Ali

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Egypt

**Facility:** Faculty of Pharmacy, Tanta University

**Status:** RECRUITING

**Zip:** 31511

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Ancestors

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000000959

- Term: Antihypertensive Agents

- ID: D000014665

- Term: Vasodilator Agents

- ID: D000014803

- Term: Vitamin B Complex

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M21946

- Name: Nicorandil

- Relevance: HIGH

- As Found: Enabling

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M17412

- Name: Vasodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000020108

- Term: Nicorandil

### Misc Info Module

- Version Holder: 2024-05-31
