Type 2 Diabetes MellitusNCT01168297
Type 2 Diabetes and Obesity in Mexican Pimas: Gene-Environment Interaction
An observational study of Type 2 Diabetes Mellitus and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in Mexico.
Trial summary
In 1995 we conducted a cross-sectional study to identify the effects of traditional and western environments on prevalence of type 2 diabetes mellitus (T2DM) and obesity in Pima Indians in Mexico and the United States. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity
- How many people
- 657 participants
- Where
- 1 siteMexico
- Study dates
- 6 Jul 2010to 7 Aug 2020
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents of Maycoba, Sonora, Mexico@@@@@@
Who may be able to join
- Selection of Subjects:
- -The entire adult population of Maycoba, Sonora, Mexico, will be invited to participate in the main study. Individuals will be eligible to participate if they are at least 18 years old and residents of Maycoba and able to give informed consent. There will be no further exclusion or inclusion criteria. For the doubly-labeled water studies pregnant women will be excluded, since pregnancy has profound effects on energy expenditure.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro de Investigacion en Alimentacion y Desarollo (CIAD)
Hermosillo
About this study
In 1995 we conducted a cross-sectional study to identify the effects of traditional and western environments on prevalence of type 2 diabetes mellitus (T2DM) and obesity in Pima Indians in Mexico and the United States. The Mexican Pimas live in a remote mountainous region and at that time had experienced little change from their traditional lifestyle. Nothing was known about their T2DM prevalence. A similar number of non-Pima Mexicans live in the same village. In contrast to the Mexican Pimas, the U.S. Pimas live in more westernized society and have a high prevalence of diabetes. We found that although T2DM and obesity were more prevalent in Mexican Pimas than non-Pimas, both Mexican groups had a significantly lower prevalence of these disorders than U.S. Pimas. The lifestyle of the Mexican population studied included a dramatically higher level of physical activity and a diet higher in fiber and lower in calories derived from fat compared with the U.S. Pimas. Since the U.S. and Mexican Pimas share a similar gene pool we concluded that even in populations genetically prone to T2DM and obesity, their development is determined largely by environmental circumstances.
Since 1995 the environmental circumstances of the Mexican Pimas and non-Pimas have changed. The electrical supply to the region has increased, cars have become more prevalent and grocery stores have appeared. The impact of these changes on T2DM and obesity has not been examined. In light of these events, we propose to: 1) compare the current prevalence of T2DM and obesity in Mexican Pimas and non-Pima Mexicans to that present in 1995 with the same measures used previously, including height, weight, waist circumference, body composition by bioelectrical impedance, oral glucose tolerance and HbA1c; 2) compare current diet, physical activity and total energy expenditure in both Mexican Pimas and. non-Pima Mexicans using the same methods as the 1995 study to the previous results and 3) document the frequencies of T2DM and obesity-associated genetic variants in Mexican Pimas compared with U.S. Pimas and non-Pima Mexicans.
Read the detailed description
In 1995 we conducted a cross-sectional study to identify the effects of traditional and western environments on prevalence of type 2 diabetes mellitus (T2DM) and obesity in Pima Indians in Mexico and the United States. The Mexican Pimas live in a remote mountainous region and at that time had experienced little change from their traditional lifestyle. Nothing was known about their T2DM prevalence. A similar number of non-Pima Mexicans live in the same village. In contrast to the Mexican Pimas, the U.S. Pimas live in more westernized society and have a high prevalence of diabetes. We found that although T2DM and obesity were more prevalent in Mexican Pimas than non-Pimas, both Mexican groups had a significantly lower prevalence of these disorders than U.S. Pimas. The lifestyle of the Mexican population studied included a dramatically higher level of physical activity and a diet higher in fiber and lower in calories derived from fat compared with the U.S. Pimas. Since the U.S. and Mexican Pimas share a similar gene pool we concluded that even in populations genetically prone to T2DM and obesity, their development is determined largely by environmental circumstances.
Since 1995 the environmental circumstances of the Mexican Pimas and non-Pimas have changed. The electrical supply to the region has increased, cars have become more prevalent and grocery stores have appeared. The impact of these changes on T2DM and obesity has not been examined. In light of these events, we propose to: 1) compare the current prevalence of T2DM and obesity in Mexican Pimas and non-Pima Mexicans to that present in 1995 with the same measures used previously, including height, weight, waist circumference, body composition by bioelectrical impedance, oral glucose tolerance and HbA1c; 2) compare current diet, physical activity and total energy expenditure in both Mexican Pimas and. non-Pima Mexicans using the same methods as the 1995 study to the previous results and 3) document the frequencies of T2DM and obesity-associated genetic variants in Mexican Pimas compared with U.S. Pimas and non-Pima Mexicans.
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Keywords
- Obesity, Type 2 Diabetes Mellitus, Genetics, Energy Expenditure, Physical Activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Motor Activity
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 |
|---|---|---|
| Maycoba residents | Pima and non-Pima Mexicans from the village of Maycoba |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes
Prevalence of diabetes
Measured: Time of examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study start6 Jul 2010
- Primary completion31 Dec 2011
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert L Hanson, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168297
- Sponsor's protocol ID
- 999910161
- Other IDs
- 10-DK-N161
- Status last verified
- Aug 2020
- First submitted
- 22 Jul 2010
- Last updated
- 14 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes and Obesity in Mexican Pimas: Gene-Environment Interaction
- ClinicalTrials.gov ID
- NCT01168297
- Acronym / sponsor ID
- 999910161
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Keywords
- Obesity, Type 2 Diabetes Mellitus, Genetics, Energy Expenditure, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 6 Jul 2010 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 23 Jul 2010 (estimated)
- 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.
In 1995 we conducted a cross-sectional study to identify the effects of traditional and western environments on prevalence of type 2 diabetes mellitus (T2DM) and obesity in Pima Indians in Mexico and the United States. The Mexican Pimas live in a remote mountainous region and at that time had experienced little change from their traditional lifestyle. Nothing was known about their T2DM prevalence. A similar number of non-Pima Mexicans live in the same village. In contrast to the Mexican Pimas, the U.S. Pimas live in more westernized society and have a high prevalence of diabetes. We found that although T2DM and obesity were more prevalent in Mexican Pimas than non-Pimas, both Mexican groups had a significantly lower prevalence of these disorders than U.S. Pimas. The lifestyle of the Mexican population studied included a dramatically higher level of physical activity and a diet higher in fiber and lower in calories derived from fat compared with the U.S. Pimas. Since the U.S. and Mexican Pimas share a similar gene pool we concluded that even in populations genetically prone to T2DM and obesity, their development is determined largely by environmental circumstances.
Since 1995 the environmental circumstances of the Mexican Pimas and non-Pimas have changed. The electrical supply to the region has increased, cars have become more prevalent and grocery stores have appeared. The impact of these changes on T2DM and obesity has not been examined. In light of these events, we propose to: 1) compare the current prevalence of T2DM and obesity in Mexican Pimas and non-Pima Mexicans to that present in 1995 with the same measures used previously, including height, weight, waist circumference, body composition by bioelectrical impedance, oral glucose tolerance and HbA1c; 2) compare current diet, physical activity and total energy expenditure in both Mexican Pimas and. non-Pima Mexicans using the same methods as the 1995 study to the previous results and 3) document the frequencies of T2DM and obesity-associated genetic variants in Mexican Pimas compared with U.S. Pimas and non-Pima Mexicans.
Detailed description
In 1995 we conducted a cross-sectional study to identify the effects of traditional and western environments on prevalence of type 2 diabetes mellitus (T2DM) and obesity in Pima Indians in Mexico and the United States. The Mexican Pimas live in a remote mountainous region and at that time had experienced little change from their traditional lifestyle. Nothing was known about their T2DM prevalence. A similar number of non-Pima Mexicans live in the same village. In contrast to the Mexican Pimas, the U.S. Pimas live in more westernized society and have a high prevalence of diabetes. We found that although T2DM and obesity were more prevalent in Mexican Pimas than non-Pimas, both Mexican groups had a significantly lower prevalence of these disorders than U.S. Pimas. The lifestyle of the Mexican population studied included a dramatically higher level of physical activity and a diet higher in fiber and lower in calories derived from fat compared with the U.S. Pimas. Since the U.S. and Mexican Pimas share a similar gene pool we concluded that even in populations genetically prone to T2DM and obesity, their development is determined largely by environmental circumstances.
Since 1995 the environmental circumstances of the Mexican Pimas and non-Pimas have changed. The electrical supply to the region has increased, cars have become more prevalent and grocery stores have appeared. The impact of these changes on T2DM and obesity has not been examined. In light of these events, we propose to: 1) compare the current prevalence of T2DM and obesity in Mexican Pimas and non-Pima Mexicans to that present in 1995 with the same measures used previously, including height, weight, waist circumference, body composition by bioelectrical impedance, oral glucose tolerance and HbA1c; 2) compare current diet, physical activity and total energy expenditure in both Mexican Pimas and. non-Pima Mexicans using the same methods as the 1995 study to the previous results and 3) document the frequencies of T2DM and obesity-associated genetic variants in Mexican Pimas compared with U.S. Pimas and non-Pima Mexicans.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maycoba residents | – | –Pima and non-Pima Mexicans from the village of Maycoba |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Maycoba, Sonora, Mexico@@@@@@
Key inclusion criteria (2 listed)
- -The entire adult population of Maycoba, Sonora, Mexico, will be invited to participate in the main study. Individuals will be eligible to participate if they are at least 18 years old and residents of Maycoba and able to give informed consent. There will be no further exclusion or inclusion criteria. For the doubly-labeled water studies pregnant women will be excluded, since pregnancy has profound effects on energy expenditure.
Key exclusion criteria (0 listed)
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
Diabetes
Time frame: Time of examination
Prevalence of diabetes
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 14 Aug 2020.
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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.
Robert L Hanson, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in Mexico.
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 2 inclusion and 0 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 14 Aug 2020. 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 Mexico. 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?
Diabetes (time frame: Time of examination). 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 14 Aug 2020.