An observational study in Type 2 Diabetes Mellitus With Complication, sponsored by Diabetes Foundation, India. Recruiting at 1 site in India. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Diabetes Foundation, India · Observational
Hypothesis: Double Hump in people with T2D is associated with higher magnitude of complication than people with single hump or no hump
Objectives: To correlate single and double hump with diabetes complication T2DM patient will be recruited from endocrine OPD
Micro Vascular
(a) Diabetic retinopathy (i) Mild NPDR (ii) Mod NPDR (iii) Macular Edema / CSME (b) Neuropathy (Mild/Mod/Severe) (c) Chronic Kidney Disease (i) Micro/Macro albumin urea (ii) Increased Creatinine (iii) Decreased eGFR
Macro Vascular
The development of type 2 diabetes mellitus (T2DM) as a major public health problem in Asian Indians. Asian Indians develop T2DM at a younger age, and progresses faster than in other ethnic groups. As a result, many diabetes complications are more prevalent and in more advanced stages in Asian countries than in other regions. Asian Indians have one of the highest incidence rates of pre-diabetes and T2DM among all major ethnic groups, and the conversion from pre-diabetes to T2DM occurs more rapidly in this population. According to the Indian Council of Medical Research- India diabetes study (57 117 individuals), the prevalence of prediabetes in all 15 states was 7·3%.
The tendency of Asian Indian to develop T2DM is enhanced by greater insulin resistance, dysglycemia, subclinical inflammation and non-alcoholic fatty liver disease (NAFLD).
"Buffalo hump," or a dorso cervical fat pad, is a term that refers to a collection of excess fat behind the neck that causes the shoulders to develop a hump-like shape. It can be caused by a variety of underlying conditions or medications.
A buffalo hump is most commonly a result of Cushing syndrome, a disorder of excess cortisol, a naturally occurring hormone that is involved in a variety of bodily processes, such as metabolism. High levels of the hormone cortisol can lead to increased fat synthesis. With Cushing syndrome, the fat produced often deposits in the neck, known as lipodystrophy. This produces the characteristic buffalo hump. Cushing syndrome may be caused by an adrenal tumor, lung tumor, or glucocorticoid medications. If Cushing syndrome is caused by a pituitary tumor, it is known as Cushing disease.
This Prospective observational study will be of 12 months' duration where 100 T2DM patients from urban areas of Delhi will be randomly screened. The population will be representative of different socio-economic strata of the society. Clinical and dietary profiles, blood pressure and phenotypic markers (acanthosis nigricans, buffalo hump, skin tags: xanthelasma, double chin, arcus, hirsutism and tendon xanthoma), diabetic retinopathy, peripheral arterial disease (PAD), neuropathy, nephropathy HTN, CHF, CT Coronary Angiography, CAD, Arrhythmias, Coronary Calcification, Cerebrovascular Disease, peripheral vascular disease, micro albumin urea, fibro scan and hand grip (average of three values) JAMAR measurement will be assessed.
To diagnose a buffalo hump and its underlying cause, a healthcare professional generally will review the individual's current medications and medical history, as well as conduct a physical examination.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 200 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Diabetes Foundation, India is the lead sponsor of 30 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with T2DM visiting Fortis CDOC Hospital will be enrolled in 2 groups cases and controls.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
T2DM with Double Dorsal Cervical Fat (Double Hump)
T2DM without Double Dorsal Cervical Fat (Double Hump)
Double Hump increases diabetes complications
Time frame: 12 months
Plan to share: No
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Diabetes Foundation, India