Study of Association of Salivary Adipokines With Prediabetes and Type 2 Diabetes Mellitus

NCT03901248 | Completed DMC

• 1 other identifier: IDRFARH005
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

India has more than 65 million adults with Type 2 Diabetes Mellitus (T2DM) and also has a large number with subclinical stages of glycaemia including impaired fasting glucose (IFG) and impaired glucose tolerance (IGT). At present people with high risk of diabetes are identified by blood test such as Oral glucose tolerance Test and/or glycosylated haemoglobin A1c (HbA1c). Dysregulated actions of adipokines have major roles in development of metabolic diseases such as diabetes. Adipokines influence systemic insulin resistance and also regulate inflammatory process and/or are likely to have major pathological role in the development of diabetes. It is also likely that these abnormalities occur even in sub clinical stages of T2DM which when identified would provide an early opportunity to institute early intervention using life style changes which are proven to be effective in all ethnic groups.The measurements of adipokines such as adiponectin, apelin, visfatin and vaspin which have inter related regulatory roles, in saliva if found to be sensitive would provide a non-invasive, simple method of assessing persons with high risk of T2DM.

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Interrelationship of adipokines such as adiponectin, apelin, visfatin and vaspin in different glycaemic stages

  Levels of adiponectin, visfatin, vaspin and apelin in prediabetes and diabetes

  Baseline and 2 years

Secondary Outcomes (7)

• Change in BMI

  Baseline and 2 years

• Change in Blood Pressure

  Baseline and 2 years

• Change in fasting blood glucose

  Baseline and 2 years

• Change in postprandial blood glucose

  Baseline and 2 years

• Comparative assessment of the sensitivity of the assays of the biomarkers in saliva and serum

  Baseline and 2 years

Study Arms (3)

Normoglycemia

Participant with normal blood glucose level with No Intervention

Other: No Intervention

Impaired Glucose Tolerance

Participants with Impaired Glucose Tolerance blood glucose level with No Intervention

Other: No Intervention

Type 2 Diabetes

Newly diagnosed type 2 diabetes patients with No Intervention

Other: No Intervention

Interventions

No Intervention OTHER

Observational study

Impaired Glucose Tolerance; Normoglycemia; Type 2 Diabetes

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normoglycemic, prediabetic and newly diagnosed Type 2 diabetic participants

You may qualify if:

• Particpants both men and women will be selected for screening using risk factors for diabetes such as age ≥ 35 years, family history of diabetes, previous history of hypertension, sedentary life-style, gestational diabetes, previous history of borderline diabetes, waist circumference ≥ 90 cm males \& ≥ 80cm in females, Body Mass Index (BMI) ≥ 23kg/m2. 2hr plasma glucose will be done for those subjects who have 3 or more risk factors.
• Arm 1: 2hr plasma glucose after 75gm of Glucose - \< 140 mg/dl
• Arm 2: 2hr plasma glucose after 75gm of Glucose - ≥ 140 mg/dl to \< 199 mg/dl
• Arm 3: 2hr plasma glucose after 75gm of Glucose - ≥ 200 mg/dl
• Have given written informed consent to participate in this study in accordance with local regulations

You may not qualify if:

• Smokers for over a period of 6 months (1 or more cigarettes per day).
• Beetle nut chewer over a period of 3 months.
• Patients with bleeding disorders
• Patients who require antibiotic prophylaxis prior to dental treatment.
• History of antibiotic therapy within 3 months prior to the study
• Patients with uncontrolled systemic disease
• Partipants who is not willing to participate in the study
• Individuals who are cognitively impaired and/or who are unable to give informed consent.

Sponsors & Collaborators

• India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals: lead

Study Officials

• Dr.Ramachandran Ambady, MD,PhD,DSc

  President, India Diabetes Research Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: April 3, 2019
• Study Start: July 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01