NCT06182618

Brief Summary

The incidence of metabolic syndrome and related diseases is gradually increasing, and diet and medication are currently common outpatient treatment methods. This study retrospectively analyzes the clinical data of patients with metabolic syndrome and related diseases who have visited our outpatient department in the past 10 years, compares the therapeutic effects of different treatment methods on their blood glucose, blood lipids, blood pressure, uric acid, and body composition, and provides evidence support for clinical treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

December 27, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 30, 2023

Last Update Submit

December 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • weight

    Weight was measured through multi-frequency bioelectrical impedance analysis InBody 720 (Bio Space Co., Seoul, Korea) at various time points

    0month/1month/2months/3 months

Secondary Outcomes (2)

  • visceral fat area(VFA)

    0month/1month/2months/3 months

  • skeletal muscle mass(SMM)

    0month/1month/2months/3 months

Study Arms (3)

low-carbohydrate diet

20-30% carbohydrates, 40-45%fat, and 30-40%protein

Other: dietary, semaglutide or/and metformin

balanced diet

50-65% carbohydrate, 20-30% fat and 10-20% protein

Other: dietary, semaglutide or/and metformin

pharmacotherapy

semaglutide (1mg per week) or/and metformin (o.5g three times a day)

Other: dietary, semaglutide or/and metformin

Interventions

patients were prescribed dietary and pharmaceuticals for weight loss

balanced dietlow-carbohydrate dietpharmacotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This was a retrospective study of the weight loss effect in 1 to 3 months in overweight or obese individuals at the department of clinical nutrition in the Second Affiliated Hospital of Zhejiang University, School of Medicine in China between 1 January 2020 and 1 Janu-ary 2024.

You may qualify if:

  • individuals who had at least a 2 follow up visits with a BMI of 24 or more with the pri-mary goal of losing weight.

You may not qualify if:

  • patients did not follow-up on a monthly basis;
  • patients followed-up less than 1 times within 3 months;
  • patients having incomplete data;
  • patients changing their interventions during fol-low-ups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Diet

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 27, 2023

Study Start

June 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

December 27, 2023

Record last verified: 2023-11

Locations