Type 2 Diabetes Mellitus With ComplicationNCT06386952
To Compare People With T2DM Who Have Double Hump Versus Who do Not Have Double Hump
An observational study of Type 2 Diabetes Mellitus With Complication, run by Diabetes Foundation, India at 1 site in India.
Trial summary
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 1. Clinical History and Examination: 1. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus With Complication
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with T2DM visiting Fortis CDOC Hospital will be enrolled in 2 groups cases and controls.
Who may be able to join
- Patients with T2DM (up to 30 years Duration)
- Age 20 to 70 years
- BMI >25 kg/m² to >40 kg/m²
- Gender- Both (Male \& Female)
Who cannot join
- Alcoholic with Moderate to Severe.
- BMI >40 kg/m²
- Congestive heart disease
- Positive hepatitis B or hepatitis C, secondary causes of fatty liver (eg. consumption of amiodarone and tamoxifen) and congestive hepatopathy.
- Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Anoop misra
New Delhi, National Capital Territory of Delhi, 110048
Anoop Misra, MD, 01149101222, anoopmisra@gmail.com
Koel Dutta, M.Sc, 01149101222, koelduttac@gmail.com
About this study
Official title: To Compare People With T2DM Who Have Double Dorsal Cervical Fat (Double Hump) Versus Who do Not Have Double Dorsal Cervical Fat (Double Hump)
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
Read more
- Clinical History and Examination:
- General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Buffalo Hump.
- Complications Assessment: Patient will be analyzed for:
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
- Low ABI/PAD
- CVD-MI/PTCA/CABG/Heart Failure
- CVS-Stroke/ TIA/Carotid Blockage >50%
Read the detailed description
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With Double Dorsal Cervical Fat | T2DM with Double Dorsal Cervical Fat (Double Hump) | |
| Without Double Dorsal Cervical Fat | T2DM without Double Dorsal Cervical Fat (Double Hump) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double Hump increases diabetes complications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus With ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
- Investigators
- Anoop Misra, MD, Principal investigator, National Diabetes Obesity and Cholesterol Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386952
- Sponsor's protocol ID
- 02/2024-2025
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare People With T2DM Who Have Double Dorsal Cervical Fat (Double Hump) Versus Who do Not Have Double Dorsal Cervical Fat (Double Hump)
- ClinicalTrials.gov ID
- NCT06386952
- Acronym / sponsor ID
- 02/2024-2025
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Clinical History and Examination:
- General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Buffalo Hump.
- Complications Assessment: Patient will be analyzed for:
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
- Low ABI/PAD
- CVD-MI/PTCA/CABG/Heart Failure
- CVS-Stroke/ TIA/Carotid Blockage >50%
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Double Dorsal Cervical Fat | – | –T2DM with Double Dorsal Cervical Fat (Double Hump) |
| Without Double Dorsal Cervical Fat | – | –T2DM without Double Dorsal Cervical Fat (Double Hump) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with T2DM visiting Fortis CDOC Hospital will be enrolled in 2 groups cases and controls.
Key inclusion criteria (4 listed)
- Patients with T2DM (up to 30 years Duration)
- Age 20 to 70 years
- BMI >25 kg/m² to >40 kg/m²
- Gender- Both (Male \& Female)
Key exclusion criteria (5 listed)
- Alcoholic with Moderate to Severe.
- BMI >40 kg/m²
- Congestive heart disease
- Positive hepatitis B or hepatitis C, secondary causes of fatty liver (eg. consumption of amiodarone and tamoxifen) and congestive hepatopathy.
- Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Double Hump increases diabetes complications
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anoop Misra, MD principal investigator
National Diabetes Obesity and Cholesterol Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus With Complication, run by Diabetes Foundation, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anoop Misra, MD (01149101222, anoopmisra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Double Hump increases diabetes complications (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.