Type 2 Diabetes MellitusT2DMNCT01275235
Exposure to Type II Diabetes for Two Siblings With the Same Parents
An observational study of Type 2 Diabetes Mellitus, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
Individuals with a family history of type 2 diabetes mellitus (T2DM) are known to be at greater risk for the disease, and studies have shown that how the body responds to insulin, how the muscle creates energy, and the amount of fat stored inside skeletal muscle are often different in these individuals at a young age… Read more about this study
- Who is it for?
- Ages 20 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Mar 2013
- 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 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community
Who may be able to join
- You are one of a sibling pair with the same mother and father, and your mother had diabetes (gestational or type 2) while she was pregnant with the younger sibling but not the older sibling.
- Your sibling is willing to participate in the study.
- You are between the ages of 20 and 34 years (inclusive)
- Your body mass index is between 20 and 29 Kg/m2 inclusive (this is a number calculated for your height and weight and indicates that you are either normal weight or overweight, but not obese).
- You are healthy as assessed by medical history and standard physical examination
- You are weight stable (your body weight has not changed .6.5 lbs over the last 3 months).
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- You do not smoke
- You provide written informed consent to participate in the study.
- You are willing to stay overnight one time at the Pennington Center.
- You have low physical activity (< 100 min of exercise per week).
Who cannot join
- You were born prematurely (<37 weeks of pregnancy)
- You are currently taking medication that may influence your body weight or metabolism.
- You have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Metabolic Traits of Adult Sib-pairs Discordant for Intrauterine Diabetes Exposure.
Individuals with a family history of type 2 diabetes mellitus (T2DM) are known to be at greater risk for the disease, and studies have shown that how the body responds to insulin, how the muscle creates energy, and the amount of fat stored inside skeletal muscle are often different in these individuals at a young age compared to people without a family history of the disease. The tendency to develop T2DM is influenced strongly by genetics; however, exposure to the surrounding environment may also play a role. The exposure to a diabetic environment while in the womb represents an altered nutritional exposure (high levels of circulating sugar, or glucose) that may affect how tissues important in regulating energy metabolism, such as the pancreas, liver, and skeletal muscle, develop. the purpose of this study is to measure sensitivity to insulin, energy expenditure, fat content of the abdomen and skeletal muscle function in young adult sibling pairs who were raised together but who are discordant for intrauterine exposure to diabetes (i.e., the mother did ot have diabetes during pregnancy with the older sibling, but did have diabetes during pregnancy with the younger sibling).
Read the detailed description
A one-time testing comprising of 2 days (32 consecutive hours). A medical history and physical including questions about medications, health status and symptoms are acquired at the fasting screening visit. Both siblings must meet all study eligibility requirements to be enrolled into the study. If enrolled for the 2 days, you will be in a metabolic chamber, dual energy x-ray absorptiometry (DXA) scan, biopsy, oral glucose tolerance test, and magnetic resonance imaging (MRI).
- Metabolic chamber is a room is a sophisticated system that allows your oxygen / carbon dioxide exchange to be measured, thereby showing the number of calories you are burning.
- DXA is a scan that measure the amount of bone, muscle, and fat in your body.
- Biopsy is a procedure to sample muscle cells from underneath the skin.
- OGTT is Oral Glucose Tolerance Test from an IV line for blood samples once you drink a sugar solution consisting of glucose.
- MRI scan is to measure the amount of fat in your abdomen around the organs and underneath the skin.
- Conditions
- Type 2 Diabetes Mellitus
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Exposure to Type II Diabetes for two siblings | Two sibling pairs with the same parents, between the ages of 20 to 34 in the Baton Rouge Area, having mother with diabetes while pregnant with one. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of type 2 diabetes mellitus (T2DM)
The purpose is to measure sensitivity to insulin, energy expenditure, fat content of the abdomen and skeletal muscle function in young adult sibling pairs who were raised together but who are discordant for intrauterine exposure to diabetes (i.e., the mother did not have diabetes during pregnancy with the older sibling, but did have diabetes during pregnancy with the younger sibling).
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: We were unable to recruit enough sibling pairs in a timely manner.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darcy Johannsen, Pennington Biomedical Research Center
- Investigators
- Darcy Johannsen, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275235
- Sponsor's protocol ID
- PBRC 10016
- Acronym
- T2DM
- Status last verified
- Apr 2016
- First submitted
- 10 Jan 2011
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Warram JH, Martin BC, Krolewski AS, Soeldner JS, Kahn CR. Slow glucose removal rate and hyperinsulinemia precede the development of type II diabetes in the offspring of diabetic parents. Ann Intern Med. 1990 Dec 15;113(12):909-15. doi: 10.7326/0003-4819-113-12-909.
PubMed 2240915Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.
PubMed 24500151
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Traits of Adult Sib-pairs Discordant for Intrauterine Diabetes Exposure.
- ClinicalTrials.gov ID
- NCT01275235
- Acronym / sponsor ID
- T2DM / PBRC 10016
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We were unable to recruit enough sibling pairs in a timely manner.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Jan 2011 (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.
Individuals with a family history of type 2 diabetes mellitus (T2DM) are known to be at greater risk for the disease, and studies have shown that how the body responds to insulin, how the muscle creates energy, and the amount of fat stored inside skeletal muscle are often different in these individuals at a young age compared to people without a family history of the disease. The tendency to develop T2DM is influenced strongly by genetics; however, exposure to the surrounding environment may also play a role. The exposure to a diabetic environment while in the womb represents an altered nutritional exposure (high levels of circulating sugar, or glucose) that may affect how tissues important in regulating energy metabolism, such as the pancreas, liver, and skeletal muscle, develop. the purpose of this study is to measure sensitivity to insulin, energy expenditure, fat content of the abdomen and skeletal muscle function in young adult sibling pairs who were raised together but who are discordant for intrauterine exposure to diabetes (i.e., the mother did ot have diabetes during pregnancy with the older sibling, but did have diabetes during pregnancy with the younger sibling).
Detailed description
A one-time testing comprising of 2 days (32 consecutive hours). A medical history and physical including questions about medications, health status and symptoms are acquired at the fasting screening visit. Both siblings must meet all study eligibility requirements to be enrolled into the study. If enrolled for the 2 days, you will be in a metabolic chamber, dual energy x-ray absorptiometry (DXA) scan, biopsy, oral glucose tolerance test, and magnetic resonance imaging (MRI).
- Metabolic chamber is a room is a sophisticated system that allows your oxygen / carbon dioxide exchange to be measured, thereby showing the number of calories you are burning.
- DXA is a scan that measure the amount of bone, muscle, and fat in your body.
- Biopsy is a procedure to sample muscle cells from underneath the skin.
- OGTT is Oral Glucose Tolerance Test from an IV line for blood samples once you drink a sugar solution consisting of glucose.
- MRI scan is to measure the amount of fat in your abdomen around the organs and underneath the skin.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure to Type II Diabetes for two siblings | – | –Two sibling pairs with the same parents, between the ages of 20 to 34 in the Baton Rouge Area, having mother with diabetes while pregnant with one. |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community
Key inclusion criteria (10 listed)
- You are one of a sibling pair with the same mother and father, and your mother had diabetes (gestational or type 2) while she was pregnant with the younger sibling but not the older sibling.
- Your sibling is willing to participate in the study.
- You are between the ages of 20 and 34 years (inclusive)
- Your body mass index is between 20 and 29 Kg/m2 inclusive (this is a number calculated for your height and weight and indicates that you are either normal weight or overweight, but not obese).
- You are healthy as assessed by medical history and standard physical examination
Key exclusion criteria (3 listed)
- You were born prematurely (<37 weeks of pregnancy)
- You are currently taking medication that may influence your body weight or metabolism.
- You have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible.
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
Risk of type 2 diabetes mellitus (T2DM)
Time frame: 2 days
The purpose is to measure sensitivity to insulin, energy expenditure, fat content of the abdomen and skeletal muscle function in young adult sibling pairs who were raised together but who are discordant for intrauterine exposure to diabetes (i.e., the mother did not have diabetes during pregnancy with the older sibling, but did have diabetes during pregnancy with the younger sibling).
Results and safety
The study was stopped early (reason given: We were unable to recruit enough sibling pairs in a timely manner.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Background: PubMed 2240915Warram JH, Martin BC, Krolewski AS, Soeldner JS, Kahn CR. Slow glucose removal rate and hyperinsulinemia precede the development of type II diabetes in the offspring of diabetic parents. Ann Intern Med. 1990 Dec 15;113(12):909-15. doi: 10.7326/0003-4819-113-12-909.
- Derived from this study: PubMed 24500151Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.
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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.
Darcy Johannsen, PhD principal investigator
Pennington Biomedical Research Center
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, run by Pennington Biomedical Research Center at 1 site in United States.
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 10 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Apr 2016. 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 United States. 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 was stopped early (reason given: We were unable to recruit enough sibling pairs in a timely manner.). Results are not available in the source record.
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?
Risk of type 2 diabetes mellitus (T2DM) (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01275235, which also lists 2 linked publications.
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 5 Apr 2016.