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NCT Number: NCT07030543

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Hospital and Research Centre

Peshawar, Khyber Pakhtunkhwa, 25100, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Individualized Dietary Plan (IDP) for Type 2 Diabetes

Behavioral

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).

Other names: Personalized Nutrition Therapy, Medical Nutrition Therapy (MNT), Diabetes-Specific Meal Plan

Usual Care

Behavioral

Standard dietary advice as per the current clinical practice.

Primary outcomes

  1. Adherence

    Time frame: Baseline to 3 months.

    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).

  2. Acceptability - Recruitment Rate

    Time frame: Enrollment to study completion (6 months)

    Assesses acceptability via recruitment rate, calculated as:

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

  3. Change in Glycemic Control (HbA1c)

    Time frame: Baseline to 3 months

    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%.

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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