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Completed

NCT Number: NCT06813131

Impact of Medical Nutrition Therapy and Follow-Up Frequency on Metabolic Syndrome Parameters

There is no study that has investigated the effects of medical nutrition therapy and more frequent follow-up via telehealth on metabolic syndrome parameters in patients with MetS who have multiple metabolic disorders such as being overweight, prediabetic/diabetic, dyslipidemic and having increased blood pressure. This study was conducted to examine the effects of medical nutrition therapy and increased follow-up via telephone calls on MetS-related parameters in individuals with MetS.

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Key information

Conditions

Metabolic Syndrome Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Obesity Metabolic Syndrome Parameters Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Kadıkoy, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals with HbA1c values <8.5%
  • Diagnosed with MetS by a physician according to the criteria declared by the consensus of the "International Diabetes Federation Task Force on Epidemiology and Prevention, National Heart, Lung, and Blood Institute, American Heart Association, World Heart Federation, International Atherosclerosis Society, and International Association for the Study of Obesity" were included.

Exclusion criteria

  • Taking anti diabetic agents other then metformin
  • Taking anti hyperlipidemic agents
  • Taking anti hypertensive agents
  • Using food supplements (w-3, chromium, multivitamins) that could affect metabolic parameters,
  • Having kidney failure,
  • Having liver failure,
  • Having immune failure
  • Having chronic gastrointestinal system disease
  • Having cancer
  • Having type 1 diabetes
  • Being pregnant or breastfeeding.

Treatment and study plan

Dietary Counseling

Other

This intervention uniquely focuses on the frequency of dietitian-led follow-up visits and their impact on metabolic syndrome-related parameters. The study includes three distinct groups with varying levels of follow-up intensity (control, intervention, and intensive intervention).

calling via telephone

Other

The intensive intervention group involves weekly diet adherence assessments via phone calls, setting it apart from other studies that typically rely on less frequent or standardized follow-up schedules. This design allows for the evaluation of how consultation frequency influences outcomes such as weight loss, blood sugar levels, lipid profile, and metabolic syndrome components."

Primary outcomes

  1. waist circumference

    Time frame: Baseline, 1 month, 2 months, and 3 months after the start of the intervention

    Waist circumference, which is an indicator of abdominal obesity, the central component of metabolic syndrome, was determined as the primary outcome because of its strong association with cardiometabolic risk and its correlation with other MetS components, and because it is a significant measure in reflecting the overall effect of the intervention.

Secondary outcomes

  1. fasting plasma glucose, triglyceride, HDL-C and blood pressure (Number of metabolic syndrome criteria)

    Time frame: Baseline, 1 month, 2 months, and 3 months after the start of the intervention

    The change in the number of individuals with the following metabolic syndrome criteria has been determined as a secondary outcome:

    • Elevated fasting plasma glucose (number of individuals with ≥100 mg/dL),
    • Elevated triglycerides (number of individuals with ≥150 mg/dL),
    • Low HDL-C (number of individuals with <50 mg/dL in women and <40 mg/dL in men),
    • Elevated blood pressure (number of individuals with systolic ≥130 mmHg and/or diastolic ≥85 mmHg).

    Multiple assessments with different units of measurement will be combined into a single reported value based on the change in the number of individuals meeting these conditions.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

The Effect of Medical Nutrition Therapy and Follow-Up Frequency on Parameters Related to Metabolic Syndrome in Individuals With Metabolic Syndrome: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2025
Registry last updated
Feb 6, 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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