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Type 2 Diabetes MellitusNCT07030543

Feasibility Of Individualized Dietary Plan (Idp) On Glycemic Control And Total Cholestrol In Diabetic Patients At Diabetes Hospital And Research Centre Peshawar

A study testing Individualized Dietary Plan (IDP) for Type 2 Diabetes in people with Type 2 Diabetes Mellitus, run by Khyber Medical University Peshawar at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to test whether a personalized meal plan (Individualized Dietary Plan, IDP) is practical and helpful for adults with type 2 diabetes in Peshawar, Pakistan. We want to see if patients can follow the IDP for 10 weeks and if it improves their blood sugar control and cholesterol levels. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Individualized Dietary Plan (IDP) for Type 2 Diabetes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 sitePakistan
Study dates
1 Feb 2025to 29 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults ≥18 years with physician-diagnosed Type 2 Diabetes Mellitus.
  • Receiving care at Diabetes Hospital and Research Centre Peshawar.
  • Willing to comply with dietary interventions and follow-up.

Who cannot join

  • Pregnant women (to exclude gestational diabetes).
  • Patients with conditions preventing dietary adherence (severe comorbidities).

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Diabetes Hospital and Research Centre

    Peshawar, Khyber Pakhtunkhwa, 25100

Other trials in Pakistan

About this study

This study aims to test whether a personalized meal plan (Individualized Dietary Plan, IDP) is practical and helpful for adults with type 2 diabetes in Peshawar, Pakistan. We want to see if patients can follow the IDP for 10 weeks and if it improves their blood sugar control and cholesterol levels. About 122 participants will be randomly assigned to either the IDP group (receiving customized diet advice) or a standard care group. We will measure their weight, blood sugar (HbA1c), cholesterol, and other health markers at the start and after 3 months. Results will show if a larger study is feasible in our local community.

Read the detailed description

Type 2 diabetes prevalence in Pakistan is high (16.98%), yet standardized dietary advice is often given without considering individual factors like age, weight, or lifestyle. Evidence shows nutrition therapy improves glycemic control, but no studies have tested personalized dietary plans in Pakistan's local population. This feasibility trial addresses this gap by evaluating the practicality of implementing IDPs at the Diabetes Hospital and Research Centre Peshawar.

Being tested
Individualized Dietary Plan (IDP) for Type 2 Diabetes, Usual care
Keywords
Type 2 Diabetes Mellitus, Glycemic Control, Cardiovascular Risk Factors, Individualized Dietary Plan (IDP)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized Dietary Plan (IDP) for Type 2 DiabetesBehavioural

    Also called Personalized Nutrition Therapy, Medical Nutrition Therapy (MNT), Diabetes-Specific Meal Plan

    This study evaluates the feasibility of an Individualized Dietary Plan (IDP), a structured, patient-tailored nutrition intervention designed to improve glycemic control and lipid profiles in adults with Type 2 Diabetes Mellitus (T2DM).

  • Usual careBehavioural

    Standard dietary advice as per the current clinical practice.

Study groups in NCT07030543
Study groupRoleWhat they receive
Individualized Dietary Plan (IDP) GroupExperimentalParticipants in this arm will receive a personalized dietary plan (IDP) tailored by a dietitian based on their BMI, glycemic levels, age, and lifestyle. The IDP includes Low-glycemic index foods (lentils, whole grains, barley), High-fiber foods (vegetables, cereals), Healthy fats (fish, walnuts, olive oil), Restricted high-sugar foods (rice, potatoes) and saturated fats (fried foods), Adherence will be monitored weekly using the Perceived Dietary Adherence Questionnaire (PDAQ) over 10 weeks.
Receives: Behavioral: Individualized Dietary Plan (IDP) for Type 2 Diabetes
Standard Care GroupActive comparatorParticipants will receive conventional dietary advice for diabetes management (non-personalized), as routinely provided at the Diabetes Hospital and Research Centre Peshawar. This includes general guidelines on carbohydrate intake, portion control, and avoidance of sugary foods, without individualized adjustments.
Receives: Behavioral: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence

    Measures participant adherence to the IDP using the Perceived Dietary Adherence Questionnaire (PDAQ).

    The scoring of the questionnaire are as follows:

    Good Adherence: Score ≥70 (consistent adherence over 10 weeks).

    Poor Adherence: Score 45-69 (inconsistent adherence over 7-9 weeks).

    Measured: Baseline to 3 months.

  2. Acceptability - Recruitment Rate

    Assesses acceptability via recruitment rate, calculated as:

    Formula: (Number of participants completing 3 month follow-up) ÷ (Number of randomized participants) × 100.

    Measured: Enrollment to study completion (6 months)

  3. Change in Glycemic Control (HbA1c)

    Measures difference in HbA1c levels (reflecting 3-month average blood glucose) between IDP and control groups.

    The threshold of glycemic control are as follows:

    Normal: <7%. Abnormal: ≥7%.

    Measured: Baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2025
  2. Study start1 Feb 2025
  3. Primary completion10 Jul 2025
  4. Study completion29 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a parallel-group, randomized, open-label feasibility trial with two arms: an intervention group receiving individualized dietary plans (IDPs) and a control group receiving standard dietary advice. Participants (n=122) will be randomly assigned using simple random sampling, with no masking (open-label) due to the nature of dietary interventions. The study will assess feasibility through adherence (PDAQ scores) and acceptability (recruitment rates), while secondary outcomes include changes in HbA1c, cholesterol, and BMI over 3 months. The design ensures practical evaluation of IDPs in a real-world clinical setting at Diabetes Hospital Peshawar.
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07030543
Sponsor's protocol ID
KMU/DIR/CTU/2024/016
Status last verified
Aug 2025
First submitted
12 Jun 2025
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie the results reported in this study will be shared with qualified researchers to support reproducibility and further scientific inquiry. This includes: Baseline characteristics (age, sex, BMI, HbA1c, cholesterol levels) Adherence scores (PDAQ questionnaire results) Outcome measures (HbA1c, total cholesterol, fasting blood sugar at 3-month follow-up)

Publications

  • Mottalib A, Salsberg V, Mohd-Yusof BN, Mohamed W, Carolan P, Pober DM, Mitri J, Hamdy O. Effects of nutrition therapy on HbA1c and cardiovascular disease risk factors in overweight and obese patients with type 2 diabetes. Nutr J. 2018 Apr 7;17(1):42. doi: 10.1186/s12937-018-0351-0.

    PubMed 29626933

  • Aamir AH, Ul-Haq Z, Mahar SA, Qureshi FM, Ahmad I, Jawa A, Sheikh A, Raza A, Fazid S, Jadoon Z, Ishtiaq O, Safdar N, Afridi H, Heald AH. Diabetes Prevalence Survey of Pakistan (DPS-PAK): prevalence of type 2 diabetes mellitus and prediabetes using HbA1c: a population-based survey from Pakistan. BMJ Open. 2019 Feb 21;9(2):e025300. doi: 10.1136/bmjopen-2018-025300.

    PubMed 30796126

  • American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.

    PubMed 30559228

Questions about this trial

What is this clinical trial studying?

A study testing Individualized Dietary Plan (IDP) for Type 2 Diabetes in people with Type 2 Diabetes Mellitus, run by Khyber Medical University Peshawar at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence (time frame: Baseline to 3 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07030543, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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