The Effect of Personalized Nutrition on Changes in Metabolic Parameters in Patients With Type 2 Diabetes Mellitus

NCT07696013 | Completed DMC

• 1 other identifier: USumateraUtara
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes mellitus (T2DM) is a multifactorial metabolic disorder commonly accompanied by obesity, hypertension, and suboptimal glycemic control, which together increase cardiovascular risk. Conventional dietary recommendations often apply a uniform approach and may not adequately address interindividual metabolic variability. Personalized nutrition has therefore gained attention as a strategy to optimize metabolic outcomes through individualized dietary interventions. This controlled intervention study evaluated the effect of a personalized nutrition program "my plate" on metabolic parameters in patients with T2DM. Participants were assigned to either an intervention group receiving personalized dietary guidance or a control group receiving standard care. Anthropometric parameters (body weight, body mass index, and waist circumference), fasting plasma glucose, and blood pressure were assessed at baseline and after the intervention

Conditions

Type 2 Diabetes

Keywords

Blood pressure; Glycemic control; Metabolic health; Obesity; Personalized nutrition; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Metabolic Profile

  Change in Fasting Plasma Glucose (mg/dL)

  Baseline, and 12 weeks

Study Arms (2)

Personalized Nutrition

EXPERIMENTAL

Intervention Group

Other: Personalized Nutrition

Generalized Nutrition

SHAM COMPARATOR

Control Group

Other: Generalized Nutrition

Interventions

Personalized Nutrition OTHER

Personalized nutrition based on individual calorie calculation is an approach that adjusts a person's energy intake and macronutrient composition according to their estimated caloric needs derived from age, sex, body weight, height, and physical activity level.

Personalized Nutrition

Generalized Nutrition OTHER

Generalized Nutrition means giving the dietary counseling that recommended by health ministry of Indonesia

Generalized Nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged \>18 years
• A confirmed diagnosis of type 2 diabetes mellitus based on the Fasting Blood Glucose more than 126 mg/dL
• Willingness to participate in dietary counseling sessions and undergo metabolic assessments throughout the study period
• Provision of written informed consent prior to participation

You may not qualify if:

• Currently following a special or therapeutic diet prescribed by a physician or dietitian
• Previous receipt of dietary counseling
• Presence of comorbid conditions known to affect metabolic function, as identified through a standardized screening questionnaire
• Use of weight-loss medications or metabolically active dietary supplements, as determined by the screening form
• Pregnancy or lactation, as assessed by medical history and physical examination

Sponsors & Collaborators

• DINA KEUMALA SARI: lead

Study Sites (1)

Nutrition Department, Universitas Sumatera Utara, Medan, Indonesia

Medan, North Sumatera, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 10, 2026
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

ID (1)