Progression From Impaired Fasting Glucose to Diabetes Mellitus Among Chinese

NCT03617757 | Completed DMC

• 1 other identifier: UW17-429
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 3

Brief Summary

Impaired fasting glucose (IFG), a significant risk factor for diabetes mellitus (DM), is commonly encountered in the primary care setting and represents an important target for DM prevention. However, data on the long term risk of progression from IFG to DM among Chinese subjects and associated risk factors are currently lacking; appropriate DM prevention programme for this group cannot be yet established. This is a prospective cohort study that aims to estimate the incidence of progression to diabetes mellitus (DM) among Chinese primary care patients with impaired fasting glucose (IFG) over a 3-year period and evaluate putative risk factors. A prospective cohort of around 700 non-diabetic Chinese adults who had IFG (i.e. fasting glucose level between 5.6 to 6.9mmol/L) and received baseline assessment between May 2013 and March 2015 at 3 public primary care clinics across Hong Kong will be invited for a 36-month-follow-up glycaemic status assessment (i.e. to repeat 75-gram oral glucose tolerance test (OGTT) and HbA1c test). The OGTT results will be used as the gold standard for the diagnosis of DM, normoglycaemia, IFG and impaired glucose tolerance (IGT) state. Demographics and lifestyle of the subjects including age, gender, occupation, education level, socio-economic status, smoking and drinking history, diet, exercise, work-sleep pattern, stress, quality of life and family history will be collected using standardized questionnaire. Participant's medical history and drug history will be retrieved from the Clinical Management System (CMS) of the Hospital Authority. Lipid profile, blood pressure, waist circumference and body mass index will also be assessed. Logistic regression model will be performed to determine if these variables are associated with progression from IFG to DM. The primary outcome is the incidence of DM among the IFG study population. The secondary outcomes are the risks of developing DM among subjects with isolated IFG or combined IFG/IGT and determinants of progression to DM. Knowledge on the natural history of isolated IFG or combined IFG/IGT among Hong Kong Chinese primary care patients and the significant modifiable associated risk factors for progression to DM will enable primary care researchers to design optimal management programme for diabetes prevention among these high risk patients.

Conditions

Progression From Impaired Fasting Glucose to Diabetes Mellitus

Keywords

Chinese; Diabetes Mellitus; Impaired fasting glucose; Incidence; Progression; Risk factors

Outcome Measures

Primary Outcomes (1)

• Incidence of DM

  the incidence of DM among Chinese primary care patients with impaired fasting glucose (including isolated IFG or combined IFG / IGT)

  At baseline

Secondary Outcomes (15)

• Incidence of regression to normoglycaemia among the studied population

  At baseline

• Family history as risk factor associated with progression to DM

  At baseline

• Smoking habit as risk factor associated with progression to DM

  At baseline

• Drinking habit as risk factor associated with progression to DM

  At baseline

• Stress level as risk factor associated with progression to DM

  At baseline

Study Arms (1)

All recruited patients

EXPERIMENTAL

Blood taking procedure, oral glucose tolerance test and questionnaire will be included.

Diagnostic Test: Oral Glucose Tolerance Test; Diagnostic Test: HbA1c

Interventions

Oral Glucose Tolerance Test DIAGNOSTIC_TEST

Patients will be invited to have oral glucose tolerance test. 2mL blood will be taken for analysis at 0 minute and 120 minutes.

All recruited patients

HbA1c DIAGNOSTIC_TEST

2mL blood will be taken for analysis of HbA1c.

All recruited patients

Eligibility Criteria

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

You may qualify if:

• Aged ≥ 18 year
• Chinese ethnicity
• Diagnosis of impaired fasting glucose (i.e. FG between 5.6-6.9mmol/L) +/- impaired glucose tolerance (i.e. 2-hour postprandial PG between 7.8-11.0mmol/L) confirmed by latest OGTT results within 60 months prior to recruitment

You may not qualify if:

• Confirmed diagnosis of DM or on hypoglycaemic treatment
• Women who are pregnant or breast-feeding at recruitment
• Patients taking glucocorticoid at recruitment
• Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment
• Severe renal impairment i.e. eGFR ≤ 30 ml/min/1.73m2
• Clinically significant anaemia at recruitment
• History of blood donation or blood transfusion within 3 months prior to recruitment

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Study Sites (3)

Tsan Yuk Hospital RAMP Clinic

Hong Kong, 852, Hong Kong

Location

Ap Lei Chau General Out-patient Clinic

Hong Kong, Hong Kong

Location

Lek Yuen General Out-patient Clinic

Hong Kong, Hong Kong

Location

Related Publications (14)

• World Health Organization, Definition and diagnosis of diabetes mellitus and intermediate hyperglycaemia. 2006, World Health Organization: Geneva.

  BACKGROUND

• Nathan DM, Davidson MB, DeFronzo RA, Heine RJ, Henry RR, Pratley R, Zinman B; American Diabetes Association. Impaired fasting glucose and impaired glucose tolerance: implications for care. Diabetes Care. 2007 Mar;30(3):753-9. doi: 10.2337/dc07-9920. No abstract available.

  PMID: 17327355 BACKGROUND

• Genuth S, Alberti KG, Bennett P, Buse J, Defronzo R, Kahn R, Kitzmiller J, Knowler WC, Lebovitz H, Lernmark A, Nathan D, Palmer J, Rizza R, Saudek C, Shaw J, Steffes M, Stern M, Tuomilehto J, Zimmet P; Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Follow-up report on the diagnosis of diabetes mellitus. Diabetes Care. 2003 Nov;26(11):3160-7. doi: 10.2337/diacare.26.11.3160. No abstract available.

  PMID: 14578255 BACKGROUND

• Task Force on Conceptual Model and Preventive Protocols, Hong Kong reference framework for diabetes care for adults in primary care settings. 2013: Hong Kong.

  BACKGROUND

• Thomas GN, Schooling CM, McGhee SM, Ho SY, Cheung BM, Wat NM, Janus ED, Lam TH; Hong Kong Cardiovascular Risk Factor Prevalence Study Steering Committee. Identification of factors differentially associated with isolated impaired fasting glucose and isolated post-load impaired glucose tolerance: the Hong Kong Cardiovascular Risk Factor Study. Eur J Endocrinol. 2006 Oct;155(4):623-32. doi: 10.1530/eje.1.02250.

  PMID: 16990663 BACKGROUND

• Ko GT, Chan JC, Cockram CS. Change of glycaemic status in Chinese subjects with impaired fasting glycaemia. Diabet Med. 2001 Sep;18(9):745-8. doi: 10.1046/j.0742-3071.2001.00572.x.

  PMID: 11606173 BACKGROUND

• Lee KF, Mak MW, Lau KO, Chung H. Risk of development of diabetes mellitus in Chinese women with persistently impaired glucose tolerance after gestational diabetes. Hong Kong Med J. 2011 Jun;17(3):195-201.

  PMID: 21636867 BACKGROUND

• Yu EY, Wong CK, Ho SY, Wong SY, Lam CL. Can HbA1c replace OGTT for the diagnosis of diabetes mellitus among Chinese patients with impaired fasting glucose? Fam Pract. 2015 Dec;32(6):631-8. doi: 10.1093/fampra/cmv077. Epub 2015 Oct 14.

  PMID: 26467644 BACKGROUND

• Rasmussen SS, Glumer C, Sandbaek A, Lauritzen T, Borch-Johnsen K. Determinants of progression from impaired fasting glucose and impaired glucose tolerance to diabetes in a high-risk screened population: 3 year follow-up in the ADDITION study, Denmark. Diabetologia. 2008 Feb;51(2):249-57. doi: 10.1007/s00125-007-0893-8. Epub 2007 Dec 5.

  PMID: 18060659 BACKGROUND

• Leiva E, Mujica V, Orrego R, Wehinger S, Soto A, Icaza G, Vasquez M, Diaz L, Andrews M, Arredondo M. Subjects with impaired fasting glucose: evolution in a period of 6 years. J Diabetes Res. 2014;2014:710370. doi: 10.1155/2014/710370. Epub 2014 Aug 20.

  PMID: 25215305 BACKGROUND

• Nichols GA, Hillier TA, Brown JB. Progression from newly acquired impaired fasting glusose to type 2 diabetes. Diabetes Care. 2007 Feb;30(2):228-33. doi: 10.2337/dc06-1392.

  PMID: 17259486 BACKGROUND

• Sharifi F, Jaberi Y, Mirzamohammadi F, Mirzamohammadi H, Mousavinasab N. Determinants of developing diabetes mellitus and vascular complications in patients with impaired fasting glucose. Indian J Endocrinol Metab. 2013 Sep;17(5):899-905. doi: 10.4103/2230-8210.117240.

  PMID: 24083174 BACKGROUND

• Toshihiro M, Saito K, Takikawa S, Takebe N, Onoda T, Satoh J. Psychosocial factors are independent risk factors for the development of Type 2 diabetes in Japanese workers with impaired fasting glucose and/or impaired glucose tolerance. Diabet Med. 2008 Oct;25(10):1211-7. doi: 10.1111/j.1464-5491.2008.02566.x.

  PMID: 19046200 BACKGROUND

• Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

  PMID: 11832527 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Disease Progression

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Prospective and Cohort study (Compare different cohorts)

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: August 6, 2018
• Study Start: October 1, 2017
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)