Diabetes Mellitus, Type 2DISFINNCT03918525
Diabetes In Sindhi Families In Nagpur (DISFIN)
An observational study of Diabetes Mellitus, Type 2, run by Lata Medical Research Foundation, Nagpur at 1 site in India.
Trial summary
The pandemic of diabetes is increasing at an alarming rate. The prevalence of diabetes has risen in India by 123% over the last decade. In 1990, diabetes was not considered an important contributor to mortality in India but in 2013, it is ranked as the eighth most common cause of deaths in adult Indian population. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Sindhi families
- How many people
- 1,462 participants
- Where
- 1 siteIndia
- Study dates
- 20 Feb 2017to 20 Feb 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: To facilitate centralized data and sample collection, we established two Participant Recruitment Centers - one each in Jaripatka and Khamla. These Centers were equipped with facilities to conduct interviews, collect anthropometric data, conduct random blood sugar measurements and collect blood and urine samples for transport and storage.
Who may be able to join
- Resident of Jaripatka or Khamla areas of Nagpur
- Self-reported Sindhi
- Age ≥20 years
- Has given informed consent
Who cannot join
- Pregnant or lactating woman
- Known type 1 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes In Sindhi Families In Nagpur (DISFIN): An Observational Study
The pandemic of diabetes is increasing at an alarming rate. The prevalence of diabetes has risen in India by 123% over the last decade. In 1990, diabetes was not considered an important contributor to mortality in India but in 2013, it is ranked as the eighth most common cause of deaths in adult Indian population. There is now a growing understanding that diabetes runs in families and has a significant genetic basis. In this regard, it is noteworthy that from an ethnographic standpoint, Sindhi population in India has been both genetically and environmentally at an increased risk of stress, hypertension and cardiovascular diseases. Considering the nexus of metabolic diseases that include hypertension, obesity, dyslipidemia and diabetes it is therefore expected that this population may be at an increased risk of these metabolic conditions. However, exact prevalence of contributors to type 2 diabetes in the Sindhi population is unknown. The proposed study will estimate prevalence of type 2 diabetes in Sindhi families of Nagpur. Both the PIs have extensive experience with family studies which includes construction of pedigrees, using variance components methods, dissecting out genetic and environmental components of diseases and association of critical phenotypic traits with disease. The proposed study will tap this resource with a focus on the Sindhi families of Nagpur which are concentrated in the Jaripatka and Khamla areas. This study will exploit the current infrastructure in the Lata Medical Research Foundation to access these families and conduct a first-of-its-kind study in India. It is expected that this study will pave way for more extensive genetic, epigenetic and environmental studies of this population. It will also foster future collaborations with national and international health agencies. In that vein, the DISFIN pilot study represents the first step towards identification, quantification, prevention and control of type 2 diabetes in central India.
Read the detailed description
At each Participant Recruitment Center:
- We announced the dates of recruitment locally through pamphlet distribution, personal conversations, emails and a study website to the residents of the study areas. When the participants came in for the study, they were first administered the informed consent form.
- Upon receiving such consent a Field Research Officer (FRO) appointed specifically for the study collected the demographic data and conduct anthropometric measurements. All the data has been directly input into a cloud-based database through tablet computers made available to the FROs for the purpose of the study.
- A trained nurse then measured the blood pressure of the participant as follows: These measurements were conducted using a random-zero sphygmomanometer on the left arm. To account for the potential variability in the blood pressure measurements, we measured the blood pressure thrice with 5-minute intervals but use the average of the last two readings as the phenotypic trait value. Appearance of the first Korotkov sound and disappearance of the fifth Korotkov sound was considered as the systolic and diastolic blood pressures, respectively.
- Thereafter the participant were under electrocardiographic evaluation. The examination was conducted by a trained ECG technician using a portable ECG machine with limb leads, chest leads and augmented leads. The signal recordings were digitized and stored as digital signal files. Novacode software was used to quantitatively measure important phenotypic traits from the ECG signals.
- The participant then proceeded to measurement of random blood glucose using a glucometer and disposable test strip. The results are shared with the participant as well as entered directly into the cloud-based database.
- Then the participant were given a urine sample collection cup. The urine sample was used to estimate urine sugar and microalbuminuria.
- The participant were then given an appointment for fasting blood studies.
- On the day of the appointment, a trained laboratory technician appointed for the purpose of the study drew 10 ml of venous blood from the ante-cubital vein. This blood sample will be used for lipid profile studies (total and free serum cholesterol, serum triglycerides, high-density lipoproteins, low-density lipoproteins, very low-density lipoproteins and apolipoproteins), fasting plasma glucose, serum cotinine (to corroborate the history of smoking), serum creatinine (to quantify urinary dilution), serum C peptide (to distinguish between type 1 and type 2 diabetes), plasma insulin and serum HbA1c (glycated hemoglobin).
- To maximize participation for the fasting blood studies, we sent text reminders to participants before the date of appointment. If the participant cannot make it on the day of appointment then we again sent text and/or telephonic reminders to them for a revised appointment date. We did this for a total of three times before the reminders can be stopped.
- If the participants were diagnosed with any medical condition during the examination then they were duly referred to expert medical help outside of the DISFIN study. If the participant was newly diagnosed as a case of T2D during study the participant was referred to expert diabetologist in the city for further medical care.
- Lastly, we provided a nominal time compensation for each participant who completed all the study procedures.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Sindhi families
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sindhi familiesOther
It is an observational study and no intervention is involved
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 diabetes
Presence of T2D will be defined as: Self-report or FPG ≥126 mg/dl or currently receiving antidiabetic drugs or HbA1c ≥6.5% or random blood sugar ≥ 200 mg/dl
Measured: March 1, 2016 - Feb 28, 2017
Secondary outcomes (5)
Insulin resistance
Insulin resistance will be measured using the Homeostatic Model of Assessment-Insulin resistance (HOMA_IR)
Measured: March 1, 2016 - Feb 28, 2017
Hypertension
Hypertension will be defined using the 2017 revised criteria (systolic blood pressure >120 mmHg and/or diastolic blood pressure >80 mmHg)
Measured: March 1, 2016 - Feb 28, 2017
Obesity
Obesity will be defined as body mass index (BMI) exceeding 30 Kg/m2. BMI will be calculated as weight (in Kg)/Height2 (in meters).
Measured: March 1, 2016 - Feb 28, 2017
Central obesity
Central obesity will be defined using population-specific cut off for waist circumference. For Asian Indians, the cutoffs are: male (>=90cm) and female (>=80 cm).
Measured: March 1, 2016 - Feb 28, 2017
Dyslipidemia
We will use the definition of dyslipidemia as described by the International Diabetes Federation (IDF). The criteria use dyslipidemia is a composite outcomes based on measured values of serum triglycerides (≥ 150 mg/dLmg/dl) and high density lipoprotein (HDL) cholesterol (< 40 mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females). Additionally, total serum cholesterol (≥200 mg/dl) will also be considered as dyslipidemia.
Measured: March 1, 2016 - Feb 28, 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start20 Feb 2017
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Cross-sectional
- Enrolment
- 1,462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lata Medical Research Foundation, Nagpur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manju R Mamtani, MD, Principal investigator, Treasurer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918525
- Sponsor's protocol ID
- RPC#23A
- Acronym
- DISFIN
- Status last verified
- Apr 2019
- First submitted
- 13 Mar 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes In Sindhi Families In Nagpur (DISFIN): An Observational Study
- ClinicalTrials.gov ID
- NCT03918525
- Acronym / sponsor ID
- DISFIN / RPC#23A
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,462 participants (actual)
- Lead sponsor
- Lata Medical Research Foundation, NagpurUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 17 Apr 2019 (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.
The pandemic of diabetes is increasing at an alarming rate. The prevalence of diabetes has risen in India by 123% over the last decade. In 1990, diabetes was not considered an important contributor to mortality in India but in 2013, it is ranked as the eighth most common cause of deaths in adult Indian population. There is now a growing understanding that diabetes runs in families and has a significant genetic basis. In this regard, it is noteworthy that from an ethnographic standpoint, Sindhi population in India has been both genetically and environmentally at an increased risk of stress, hypertension and cardiovascular diseases. Considering the nexus of metabolic diseases that include hypertension, obesity, dyslipidemia and diabetes it is therefore expected that this population may be at an increased risk of these metabolic conditions. However, exact prevalence of contributors to type 2 diabetes in the Sindhi population is unknown. The proposed study will estimate prevalence of type 2 diabetes in Sindhi families of Nagpur. Both the PIs have extensive experience with family studies which includes construction of pedigrees, using variance components methods, dissecting out genetic and environmental components of diseases and association of critical phenotypic traits with disease. The proposed study will tap this resource with a focus on the Sindhi families of Nagpur which are concentrated in the Jaripatka and Khamla areas. This study will exploit the current infrastructure in the Lata Medical Research Foundation to access these families and conduct a first-of-its-kind study in India. It is expected that this study will pave way for more extensive genetic, epigenetic and environmental studies of this population. It will also foster future collaborations with national and international health agencies. In that vein, the DISFIN pilot study represents the first step towards identification, quantification, prevention and control of type 2 diabetes in central India.
Detailed description
At each Participant Recruitment Center:
- We announced the dates of recruitment locally through pamphlet distribution, personal conversations, emails and a study website to the residents of the study areas. When the participants came in for the study, they were first administered the informed consent form.
- Upon receiving such consent a Field Research Officer (FRO) appointed specifically for the study collected the demographic data and conduct anthropometric measurements. All the data has been directly input into a cloud-based database through tablet computers made available to the FROs for the purpose of the study.
- A trained nurse then measured the blood pressure of the participant as follows: These measurements were conducted using a random-zero sphygmomanometer on the left arm. To account for the potential variability in the blood pressure measurements, we measured the blood pressure thrice with 5-minute intervals but use the average of the last two readings as the phenotypic trait value. Appearance of the first Korotkov sound and disappearance of the fifth Korotkov sound was considered as the systolic and diastolic blood pressures, respectively.
- Thereafter the participant were under electrocardiographic evaluation. The examination was conducted by a trained ECG technician using a portable ECG machine with limb leads, chest leads and augmented leads. The signal recordings were digitized and stored as digital signal files. Novacode software was used to quantitatively measure important phenotypic traits from the ECG signals.
- The participant then proceeded to measurement of random blood glucose using a glucometer and disposable test strip. The results are shared with the participant as well as entered directly into the cloud-based database.
- Then the participant were given a urine sample collection cup. The urine sample was used to estimate urine sugar and microalbuminuria.
- The participant were then given an appointment for fasting blood studies.
- On the day of the appointment, a trained laboratory technician appointed for the purpose of the study drew 10 ml of venous blood from the ante-cubital vein. This blood sample will be used for lipid profile studies (total and free serum cholesterol, serum triglycerides, high-density lipoproteins, low-density lipoproteins, very low-density lipoproteins and apolipoproteins), fasting plasma glucose, serum cotinine (to corroborate the history of smoking), serum creatinine (to quantify urinary dilution), serum C peptide (to distinguish between type 1 and type 2 diabetes), plasma insulin and serum HbA1c (glycated hemoglobin).
- To maximize participation for the fasting blood studies, we sent text reminders to participants before the date of appointment. If the participant cannot make it on the day of appointment then we again sent text and/or telephonic reminders to them for a revised appointment date. We did this for a total of three times before the reminders can be stopped.
- If the participants were diagnosed with any medical condition during the examination then they were duly referred to expert medical help outside of the DISFIN study. If the participant was newly diagnosed as a case of T2D during study the participant was referred to expert diabetologist in the city for further medical care.
- Lastly, we provided a nominal time compensation for each participant who completed all the study procedures.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- To facilitate centralized data and sample collection, we established two Participant Recruitment Centers - one each in Jaripatka and Khamla. These Centers were equipped with facilities to conduct interviews, collect anthropometric data, conduct random blood sugar measurements and collect blood and urine samples for transport and storage.
Key inclusion criteria (4 listed)
- Resident of Jaripatka or Khamla areas of Nagpur
- Self-reported Sindhi
- Age ≥20 years
- Has given informed consent
Key exclusion criteria (2 listed)
- Pregnant or lactating woman
- Known type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sindhi familiesIt is an observational study and no intervention is involved | Other | – |
Primary outcome
Type 2 diabetes
Time frame: March 1, 2016 - Feb 28, 2017
Presence of T2D will be defined as: Self-report or FPG ≥126 mg/dl or currently receiving antidiabetic drugs or HbA1c ≥6.5% or random blood sugar ≥ 200 mg/dl
5 secondary outcomes
Insulin resistance
Time frame: March 1, 2016 - Feb 28, 2017
Hypertension
Time frame: March 1, 2016 - Feb 28, 2017
Obesity
Time frame: March 1, 2016 - Feb 28, 2017
Central obesity
Time frame: March 1, 2016 - Feb 28, 2017
Dyslipidemia
Time frame: March 1, 2016 - Feb 28, 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Manju R Mamtani, MD principal investigator
Treasurer
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 Diabetes Mellitus, Type 2, run by Lata Medical Research Foundation, Nagpur 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 2 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: finished, as of the sponsor's last update on 17 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 2 diabetes (time frame: March 1, 2016 - Feb 28, 2017). 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 17 Apr 2019.