NCT05322551

Brief Summary

Obesity is a major risk factor for Type 2 Diabetes (T2D) and cardiovascular diseases, such as hypertension and dyslipidemia. Recently, weight loss surgery (i.e., metabolic or bariatric surgery) has been shown to result in very good long-term glycemic control in patients with T2D and obesity. However, knowledge and data on molecular levels and metabolomics are still limited. This study will fill in these gaps and provide potential biomarkers for T2D. Lifestyle and dietary practices (LDP) influence the clinical outcome and metabolites in T2D. Although the roles of LDP is critical in ensuring optimal clinical outcomes, data is still limited especially on relating the LDP and metabolomics in T2D.

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
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 24, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

December 7, 2021

Last Update Submit

August 29, 2022

Conditions

Obesity; EndocrineDiabete Type 2PreDiabetes

Keywords

Bariatric surgeryMetabolic surgery

Outcome Measures

Primary Outcomes (14)

  • Body weight changes

    Body weight changes

    6 months

  • Body weight changes

    Body weight changes

    12 months

  • Body mass index (BMI) changes

    Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters)

    6 months

  • Body mass index (BMI) changes

    Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters)

    12 months

  • Body Fat Percentage changes

    Body Fat Percentage changes measured in percentage

    6 months

  • Body Fat Percentage changes

    Body Fat Percentage changes measured in percentage

    12 months

  • Fasting Blood Glucose changes

    Fasting Blood Glucose changes measured in mmol/L

    6 months

  • Fasting Blood Glucose changes

    Fasting Blood Glucose changes measured in mmol/L

    12 months

  • HbA1c changes

    HbA1c changes measured in percentage

    6 months

  • HbA1c changes

    HbA1c changes measured in percentage

    12 months

  • Changes of metabolites profile

    Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)

    6 months

  • Changes of metabolites profile

    Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)

    12 months

  • Changes in lipid related biochemical parameters

    Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L

    6 months

  • Changes in lipid related biochemical parameters

    Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L

    12 months

Secondary Outcomes (2)

  • Quality of Life changes

    At baseline, month 6 and month 12

  • Dietary Intake changes

    At baseline, month 6 and month 12

Study Arms (3)

Obese only

Definition of Obese: Body Mass Index ≥ 30kg/m\^2 (WHO classification) Definition of Non Diabetes: Fasting Plasma Glucose (FPG) \< FPG 100 mg/dL (5.6 mmol/L)

Obese with prediabetes

Definition of Obese: Body Mass Index ≥ 30kg/m\^2 (WHO classification) Definition of Prediabetes: FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) OR A1C 5.7-6.4% (39-47 mmol/mol)

Obese with diabetes

Definition of Obese: Body Mass Index ≥ 30kg/m\^2 (WHO classification) Definition of Diabetes: (American Diabetes Association, 2020) FPG ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.\* OR A1C ≥6.5% (48 mmol/mol).

Eligibility Criteria

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

All subjects with obesity (Body Mass Index ≥ 30kg/m2 \[WHO classification\])) and diagnosed with pre-diabetes, T2D and non-diabetic (healthy) who are undergoing metabolic surgery at Hospital Kuala Lumpur will be recruited. Healthy individuals will be recruited as controls for reference range

You may qualify if:

  • BMI \> 30kg/m2
  • Men and women
  • Ages 18-65 years old
  • Diabetes status (non diabetic, pre diabetes and diabetes)
  • Patients who will undergo metabolic surgery
  • BMI \< 30kg/m2,
  • Men and women
  • Ages 18-65 years old
  • No diabetes
  • No pre diabetes
  • No other co-morbidities (high total cholesterol, high triglycerides, high blood pressure)

You may not qualify if:

  • BMI \<30 kg/m2
  • Use of medications that may affect body weight at screening or during a 3 month period prior
  • Other medical conditions like Cushing's, acromegaly, Heart failure, Crohn's disease, etc
  • Alcohol dependence
  • BMI \> 30 kg/m2 (obese)
  • BMI \< 18.5 kg/m2 (underweight)
  • Diabetes status (pre diabetes and diabetes)
  • Use of medications that may affect body weight at screening or during a 3 month period prior
  • Other co-morbidities (high total cholesterol, high triglycerides, high blood pressure, cancer)
  • Other medical conditions like Cushing's, acromegaly, Heart failure, Crohn's disease, etc
  • Alcohol dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Medical Research, National Institutes of Health

Shah Alam, Selangor, 40170, Malaysia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected for serum/plasma during baseline and 6 \& 12 month follow-up Adipose tissue (omentum, visceral) will be collected during surgery. Venous blood samples (20mL = 4 teaspoons) will be collected prior to surgery, 6 month and 1 year postoperatively. The plasma samples will be obtained by centrifugation at 800 g for 15 min, and the aliquots will be transferred to polypropylene tubes and stored at -80°C until they are assayed. Total RNA and miRNA will be isolated according to manufacturer instructions. The first morning urine samples (minimum 30mL) will be collected. Frozen tubes will be used and stored at -80 °C until processing for Nuclear Magnetic Resonance (NMR) analysis.

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Prediabetic State

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Fazliana Mansor, PhD

    Institute for Medical Research, Setia Alam, Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fazliana Mansor, PhD

CONTACT

+60162280081fazliana.m@moh.gov.my

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Officer

Study Record Dates

First Submitted

December 7, 2021

First Posted

April 12, 2022

Study Start

June 24, 2022

Primary Completion

January 1, 2023

Study Completion

December 1, 2024

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations

MY(1)