ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624000777594

Ethics application status

Approved

Date submitted

16/01/2024

Date registered

25/06/2024

Date last updated

25/06/2024

Date data sharing statement initially provided

25/06/2024

Date results provided

25/06/2024

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effects of chromium picolinate as an adjuvant on HbA1c levels in diabetic patients, and on eGFR and serum creatinine levels in diabetes induced renal impaired patients.

Scientific title

Effects of chromium picolinate as an adjuvant on HbA1c levels in diabetic patients, and on eGFR and serum creatinine levels in diabetes induced renal impaired patients.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1300-7022

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Diabetes Induced Renal Impairment

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Renal and Urogenital

Kidney disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants in this group received a combination treatment of chromium picolinate alongside their existing hypoglycemic medications. Hypoglycemic agents dosage must be stable for at least 60 days prior to entering trial. This additional therapy involves administering a 500 µg chromium picolinate tablet once daily for an extended period of 45 days. To monitor compliance, participants were asked to bring all remaining tablets along with medication containers to their final visit. Adherence was assessed by counting the unused tablets and verifying the completeness of dosing records in their diaries.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Participants in the control group maintained their pre-existing antidiabetic medication regimen, which include drugs from the anti-diabetic drug classes such as biguanides, sulfonylureas, and dipeptidyl peptidase-4 (DPP-4 inhibitors). Medication dosage must be stable for at least 60 days prior to entering trial.

Control group

Active

Outcomes

Primary outcome [1]

Glycated hemoglobin (HbA1c) concentration was determined as a percentage of total hemoglobin using Cobas b 101. test system.

Timepoint [1]

At baseline and at 45 days post intervention commencement.

Primary outcome [2]

Serum creatinine concentration was determined quantitatively in milligrams per deciliter (mg/dL) using a Roche Cobas Analyzer employing the Jaffé Gen.2 kinetic colorimetric assay. In this method, creatinine reacts with picric acid under alkaline conditions to form a yellow-orange complex, with the rate of color formation proportional to creatinine concentration.

Timepoint [2]

At baseline and at 45 days post intervention commencement.

Primary outcome [3]

Participants eGFR was assessed by using the Cockcroft-Gault equation.
For male participants: eGFR = 175*((creatinine)^-1.154)*((age)^-0.203)
For female participants: eGFR = = 175*((creatinine)^-1.154)*((age)^-0.203)*0.742

Timepoint [3]

At baseline and at 45 days post intervention commencement.

Secondary outcome [1]

"Serum total cholesterol (TC) concentration was determined quantitatively in milligrams per deciliter (mg/dL) as part of the lipid profile using the Cobas C system. The analysis likely employed an enzymatic colorimetric assay, where cholesterol esters are hydrolyzed, and the released cholesterol is oxidized to produce a colored product.

Timepoint [1]

At baseline and at 45 days post intervention commencement.

Secondary outcome [2]

Serum low-density lipoprotein cholesterol (LDL-C) concentration was determined in milligrams per deciliter (mg/dL) as part of the lipid profile using the Cobas C system. The analysis employed homogeneous enzymatic colorimetric assay for direct measurement of LDL-C.

Timepoint [2]

At baseline and at 45 days post intervention commencement.

Secondary outcome [3]

Serum very-low-density lipoprotein cholesterol (VLDL-C) concentration was estimated in milligrams per deciliter (mg/dL) as part of the lipid profile. The calculation employed the Friedewald equation (VLDL-C = Triglycerides / 5), where triglyceride concentration was directly measured.

Timepoint [3]

At baseline and at 45 days post intervention commencement.

Secondary outcome [4]

Serum high-density lipoprotein cholesterol (HDL-C) concentration was determined quantitatively in milligrams per deciliter (mg/dL) as part of the lipid profile using the Cobas C system. The analysis likely employed a homogeneous enzymatic colorimetric method for selective measurement of HDL-C

Timepoint [4]

At baseline and at 45 days post intervention commencement.

Secondary outcome [5]

Serum triglyceride concentration was determined quantitatively in milligrams per deciliter (mg/dL) as part of the lipid profile using the Cobas C Roche/Hitachi system. The analysis likely employed an enzymatic colorimetric assay, where triglycerides are hydrolyzed to glycerol and fatty acids, followed by a series of reactions ultimately producing a measurable colored product.

Timepoint [5]

At baseline and at 45 days post intervention commencement.

Secondary outcome [6]

Urinary creatinine concentration was determined quantitatively in milligrams per deciliter (mg/dL) using a Roche Cobas C analyzer. The analysis likely employed the Jaffé kinetic method, where creatinine reacts with picric acid under alkaline conditions to form a colored complex.

Timepoint [6]

At baseline and at 45 days post intervention commencement.

Secondary outcome [7]

Urinary protein concentration was determined quantitatively in milligrams per deciliter (mg/dL) using a Roche Cobas C analyzer.

Timepoint [7]

At baseline and at 45 days post intervention commencement.

Secondary outcome [8]

The Urine Protein/Creatinine Ratio (UPCR) is a dimensionless value calculated by using formula : UPCR = Urine Protein Concentration (mg/dL) / Urine Creatinine Concentration (mg/dL)

Timepoint [8]

At baseline and at 45 days post intervention commencement.

Secondary outcome [9]

Body weight was determined in kilograms (kg) using a calibrated digital weighing balance. Participants were instructed to stand with minimal clothing and shoes removed, with weight evenly distributed on both feet.

Timepoint [9]

At baseline and at 45 days post intervention commencement.

Secondary outcome [10]

Waist circumference (WC) was determined in centimeters by measuring the midpoint between the lower margin of the last palpable rib and the top of the iliac crest, just above the belly button with a flexible, non-stretchable tape measure.

Timepoint [10]

At baseline and at 45 days post intervention commencement.

Secondary outcome [11]

Hip circumference (HC) was determined in centimeters by measuring the widest circumference around the buttocks, ensuring the tape measure remained parallel to the floor.

Timepoint [11]

At baseline and at 45 days post intervention commencement.

Secondary outcome [12]

Body Mass Index (BMI) was calculated by dividing participants' body weight in kilograms (kg) by the square of their height in meters (m²).

Timepoint [12]

At baseline and at 45 days post intervention commencement.

Secondary outcome [13]

Systolic blood pressure (SBP) was measured in millimeters of mercury (mmHg) using the auscultatory method with a calibrated sphygmomanometer and stethoscope. Participants were seated in a relaxed position with their arm supported at heart level, and the measurement was taken over the brachial artery.

Timepoint [13]

At baseline and at 45 days post intervention commencement.

Secondary outcome [14]

Diastolic blood pressure was measured in millimeters of mercury (mmHg) using the auscultatory method with a calibrated sphygmomanometer and stethoscope. Participants were seated in a relaxed position with their arm supported at heart level, and the measurement was taken over the brachial artery.

Timepoint [14]

At baseline and at 45 days post intervention commencement.

Secondary outcome [15]

Standing height was measured in centimeters (cm) using a stadiometer. Participants were instructed to stand barefoot with their heels together, back straight against the stadiometer, and head positioned in the Frankfort horizontal plane (looking straight ahead)."

Timepoint [15]

At baseline and at 45 days post intervention commencement.

Secondary outcome [16]

A patient self-reporting technique was employed to monitor the occurrence of any new or worsening neurological symptoms throughout the duration of the trial. Participants were instructed to decribe symptoms suggestive of neurological adverse event such as seizures, motor dysfunction and changes in cognition, mood, or behavior.

Timepoint [16]

Subjects were contacted at Days 15 and 30 post intervention commencement by the call center and reminded to report all neurological adverse events. Patients were canvassed verbally at their final visit as to whether they had experienced any neurological adverse event

Secondary outcome [17]

A patient self-reporting technique was employed to monitor the occurrence of any new or worsening Gastrointestinal symptoms throughout the duration of the trial. Participants were instructed to decribe symptoms suggestive of gastrointestinal adverse event such as nausea, vomiting, bloating, constipation and abdominal pain.

Timepoint [17]

Subjects were contacted at Days 15 and 30 post intervention commencement by the call center and reminded to report all gastrointestinal adverse events. Patients were canvassed verbally at their final visit as to whether they had experienced any gastrointestinal adverse events.

Secondary outcome [18]

A patient self-reporting technique was employed to monitor for any new or worsening skin or tissue adverse events throughout the trial. Participants were instructed to decribe symptoms suggestive of skin and tissue adverse event such as tenderness, rash, edema and skin irritation.

Timepoint [18]

Subjects were contacted at Days 15 and 30 post intervention commencement by the call center and reminded to report any new or worsening skin or tissue adverse events. Patients were also canvassed verbally at their final visit to inquire about any skin or tissue adverse events they may have experienced

Secondary outcome [19]

A patient self-reporting technique was employed to monitor for any new or worsening musculoskeletal adverse events throughout the trial. Participants were instructed to decribe symptoms suggestive of musculoskeletal adverse event such as pain, stiffness, weakness, or limitations in movement.

Timepoint [19]

Subjects were contacted at Days 15 and 30 post intervention commencement by the call center and reminded to report any new or worsening of musculoskeletal adverse events. Patients were also canvassed verbally at their final visit to inquire about any musculoskeletal adverse events they may have experienced.

Secondary outcome [20]

A patient self-reporting technique was employed to monitor for any new or worsening symptoms suggestive of metabolic events throughout the trial. Participants were instructed to decribe symptoms suggestive of metabolic event such as thirst, fatigue, changes in appetite, or frequent urination.

Timepoint [20]

Subjects were contacted at Days 15 and 30 post intervention commencement by the call center and reminded to report any new or worsening of metabolic adverse events. Patients were also canvassed verbally at their final visit to inquire about any metabolic adverse events they may have experienced.

Secondary outcome [21]

A patient self-reporting technique was employed to capture any new or worsening symptoms potentially related to general medical conditions throughout the trial. Participants were instructed to decribe symptoms suggestive of general medical conditions, such as hypertension, arrhythmias, anemia and arthritis.

Timepoint [21]

Subjects were contacted at Days 15 and 30 post intervention commencement by the call center and reminded to report any new or worsening of general medicine events. Patients were also canvassed verbally at their final visit to inquire about any general medicine adverse events they may have experienced.

Secondary outcome [22]

A patient self-reporting technique was employed to capture any new or worsening symptoms potentially related to immune system throughout the trial. Participants were instructed to decribe symptoms suggestive of immune reactions, such as runny nose, cough, shortness of breath, and swalloen lymph nodes.

Timepoint [22]

Subjects were contacted at Days 15 and 30 post intervention commencement by the call center and reminded to report any new or worsening of immune system events. Patients were also canvassed verbally at their final visit to inquire about any immune system adverse events they may have experienced.

Secondary outcome [23]

A patient self-reporting system was employed to capture the incidence of hypoglycemic events. Participants were instructed to describe about the symptoms suggestive of hypoglycemia, such as sweating, dizziness, shakiness, confusion, and hunger. A glucose monitoring device was used randomly with objective blood glucose measurements.

Timepoint [23]

Subjects were contacted at Days 15 and 30 post intervention commencement by the call center and reminded to report any new or worsening of hypoglycemic events. Patients were also canvassed verbally at their final visit to inquire about any hypoglycemic adverse events they may have experienced.

Eligibility

Key inclusion criteria

1) Men and Women 26 - 70 years old
2) Patients having HBA1C greater than 7.0%
3) Diagnosis of type-2 DM greater than or equal to 12 months
4) Patients currently taking anti-diabetic drugs (ADD), stable for greater than or equal to 60 days prior to entry
5) Patients who give informed consent

Minimum age

26 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

The exclusion criteria for the participants were as follow
1) Chromium Picolinate supplementation in lasst 90 days before the start of the trial in any form greater than or equal to 120µg/d.
2) Acute Conditions like stroke
3) Patients having hepatic diseases
4) Patients with Alcohol or drugs abuse
5) Issues with the subject's mental health that would prohibit them from finishing the
study
6) Female with pregnancy or breast feeding
7) Failure to give informed consent

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes (SNOSE) were employed. The treatment assignments were placed within the SNOSE by a researcher not involved in participant recruitment or assessment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomization schedule was generated using validated computer software, employing a blocked randomization design with fixed block sizes of six subjects per treatment arm.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

5/10/2022

Date of last participant enrolment

Anticipated

Actual

12/10/2022

Date of last data collection

Anticipated

Actual

15/12/2022

Sample size

Target

140

Accrual to date

Final

100

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Punjab

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr. Muhammad Bilal Liaqat

Address [1]

Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Rd, Faisalabad City, Punjab 38000

Country [1]

Pakistan

Funding source category [2]

Hospital

Name [2]

T.H.Q Hospital Jaranwala

Address [2]

Country [2]

Pakistan

Funding source category [3]

University

Name [3]

Government College University Faisalabad

Address [3]

Country [3]

Pakistan

Primary sponsor type

Individual

Name

Dr. Malik Hassan Mehmood

Address

Chairperson Office, Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Faisalabad city-38000

Country

Pakistan

Secondary sponsor category [1]

Individual

Name [1]

Dr. Rida Siddique

Address [1]

Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Rd, Faisalabad City, Punjab 38000

Country [1]

Pakistan

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Review Board, Government College University Faisalabad

Ethics committee address [1]

Kotwali Rd, Government College University, Faisalabad City, Punjab 38000

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

Approval date [1]

11/09/2022

Ethics approval number [1]

GCUF/ERC/ 186

Summary

Brief summary

Chromium picolinate supplement was investigated as a potential adjuvant therapy for managing diabetes mellitus and its associated renal complications. This randomized single-blind clinical trial aimed to evaluate the efficacy and safety of Picomium in controlling HbA1c levels, improving serum creatinine and eGFR and mitigating other metabolic parameters in diabetes and diabetic-induced renally impaired patients. The study  involved 45 days of treatment with Picomium tablets containing 500mcg of chromium picolinate administered once daily as an adjuvant to already prescribed anti-diabetic medications. Comprehensive clinical monitoring and assessment was conducted throughout the study, including the reporting of any adverse events. Treatment was well tolerated with no adverse effects dissimilar from control.   
Chromium picolinate supplement given as Picomium manufactured by Nutrix Healthcare, a leading pharmaceutical company based in Faisalabad, Pakistan. Picomium is a registered product with DRAP registration number DRAP-14935, indicating that it has been reviewed and approved by the Drug Regulatory Authority of Pakistan (DRAP) for sale in Pakistan. 
The findings of this trial contributes to the growing body of knowledge regarding the potential benefits of chromium picolinate supplementation in diabetes management. .

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Muhammad Bilal Liaqat

Address

Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Allama Iqbal Road, Faisalabad-38000,Punjab-Pakistan

Country

Pakistan

Phone

+923350048595

Fax

Email

[email protected]

Contact person for public queries

Name

Muhammad Bilal Liaqat

Address

Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Allama Iqbal Road, Faisalabad-38000,Punjab-Pakistan

Country

Pakistan

Phone

+923350048595

Fax

Email

[email protected]

Contact person for scientific queries

Name

Muhammad Bilal Liaqat

Address

Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Allama Iqbal Road, Faisalabad-38000,Punjab-Pakistan

Country

Pakistan

Phone

+923350048595

Fax

Email

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All data after de-identification shall be shared.

When will data be available (start and end dates)?

Immediately following publication, no end date.

Available to whom?

Anyone who wishes to access it, only researchers who provide a methodologically sound proposal at discretion of Principal Investigator.

Available for what types of analyses?

Available for meta-analysis

How or where can data be obtained?

By email to Principal Investigator at [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
20999	Informed consent form				Informed consent shall be shared only as an eviden... [More Details]
21000	Ethical approval					383276-(Uploaded-23-11-2023-02-10-10)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.