DiabetesGlasVEGASNCT02399423
The GlasVEGAS Study (Glasgow Visceral & Ectopic Fat With Weight Gain in South AsianS)
A study testing Weight gain and Weight loss in people with Diabetes and Weight Gain, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
South Asians have a much higher risk of diabetes compared to Europeans and investigators don't know why this is. Investigators think that South Asians' capacity to store fat safely under the skin is lower than Europeans, so they start to store fat around internal organs and in liver and muscle, and at lower body… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Weight Gain, Weight Loss
- What is being tested?
- Weight gain and Weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Mar 2015to 4 Jul 2018
- Phase
- Interventional
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be men of European (self-report of both parents of white European origin) or South Asian (self-report of both parents of Indian, Pakistani, Bangladeshi or Sri Lankan origin) with BMI <25 kg.m-2, who have been weight stable (± 2 kg) for >6 months.
Who cannot join
- Exclusion criteria will include diabetes (physician diagnosed or HbA1c ≥6.5% on screening), history of cardiovascular disease, regular participation in vigorous physical activity, current smoking, taking drugs or supplements thought to affect carbohydrate or lipid metabolism, or other significant illness that would prevent full participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The GlasVEGAS Study (Glasgow Visceral & Ectopic Fat With Weight Gain in South AsianS) - Does Adipose Tissue Expandibility Differ Between South Asians and Europeans and Does This Contribute to Differences in Cardio-metabolic Disease Risk?
South Asians have a much higher risk of diabetes compared to Europeans and investigators don't know why this is. Investigators think that South Asians' capacity to store fat safely under the skin is lower than Europeans, so they start to store fat around internal organs and in liver and muscle, and at lower body weights than Europeans. These increased levels of internal fat storage are thought to increase risk of diabetes.
The purpose of the study therefore is to investigate whether there are differences with weight gain and weight loss in fat storage, fat cell function and metabolic risk factors, in South Asians compared with Europeans. Investigators will compare South Asian and European men at the start of the study, after they have gained about 7% body weight, and again after they have lost 7-15% body weight (from peak weight) to see how gaining and losing weight affects fat storage within the body and the function of fat cells. Investigators will also assess the effect of weight gain and weight loss on metabolism, fitness and risk factors for diabetes and heart disease.
Read the detailed description
South Asians have about five times the risk of adult onset diabetes (high blood sugar) than Europeans and nearly one in five South Asian men in the United Kingdom have the disease. Diabetes is a serious disease that can lead to a number of adverse health consequences including heart disease, kidney disease and blindness and accounts for about 10% of all healthcare costs in the UK. Obesity is strongly linked to diabetes risk, but the adverse effect of getting fatter on diabetes risk is much higher in South Asians than Europeans. The purpose of this study is to understand why this is the case. When humans put on weight initially this fat is stored under the skin (subcutaneous fat). This is relatively safe. However, when the capacity of this under skin storage is exceeded, fat is stored internally within the tummy area (visceral fat) and in organs such as the liver and muscle, which is less safe and increases diabetes risk. Investigators think that South Asians' capacity to store fat safely under the skin is lower than Europeans, so fat is stored internally and in liver and muscle at lower body weights than Europeans. The purpose of this study is to investigate whether this occurs and why. To do this investigators will compare a group of South Asian and European men and see how gaining and losing weight affects fat storage within the body and the function of fat cells. Investigators will also assess the effect of weight gain and weight loss on metabolism, fitness and risk factors for diabetes and heart disease.
The study will include healthy men of normal weight aged between 18-45 year and of either white European or South Asian (both parent of Indian, Pakistani, Bangladesh or Sri Lankan origin) ethnic origin.
Body weight will be altered by initially gaining weight and then losing weight. To do this participants will initially have to eat more food for 4-6 weeks and then go on a diet combined with exercise for 12 weeks. Participation in the study will last around 5½ months in total.
During the study pictures of body fat stores will be taken using an MRI scanner, a biopsy/sample of tummy fat will be taken to look at the fat cells and physical fitness and body metabolism (the way the body deals with sugar, insulin and fat) will be measured. These measurements will be done at three different times: before gaining weight, once weight is gained, and after losing weight (and back to original weight). The measurements will give a detailed assessment of the changes in the body when gaining or losing weight.
The benefits of taking part in the study are receiving detailed feedback about fitness levels, body fat, dietary intake, blood pressure, cholesterol, blood sugar and level of "insulin resistance". Feedback about the overall study findings will also be provided.
In addition, the knowledge gained from participation may benefit people who are at risk of diabetes in the future by increasing our understanding of why South Asians are at increased risk of developing diabetes. It will also help guide future research investigating how to reduce this increased risk through lifestyle changes and may also help direct the development of medicines to prevent and treat diabetes groups at increased risk of the disease.
Possible disadvantages of the study are gaining 7% of body weight over 4-6 weeks. This is likely to temporarily induce negative metabolic changes. However, investigators are also supporting losing this weight (and hopefully more) in the weight loss phase of the study. There is no evidence that short-term weight gain of this nature causes any long-term adverse effects. Longer-term weight gain however is associated with an increased risk of diabetes, cardiovascular disease and high blood pressure. It is therefore important that investigators ensure participants return to original weight at the start of the study. Taking fat biopsies carries a small risk of minor bruising or an infection. Good sterile practice reduces this risk of infection and application of ice and pressure to the biopsy site reduces the risk of bruising. Blood sampling via the cannula may cause minor bruising or an inflammation of the vein. Some participants may feel faint when they give blood. One of the exercise tests will be at a maximal level and the possibility exists that, very occasionally, certain changes may occur during or shortly after the test. They include abnormal blood pressure, fainting or a change in the normal rhythm of the heartbeat. There is a small possibility that taking part in this study will reveal a health problem that patients already have such as high cholesterol or high blood pressure. If such a problem is revealed, investigators will ask permission to inform the participant's General Practitioner to receive clinically appropriate follow-up care.
This study is running for ~2.5 years from March 2015 and is based at the University of Glasgow. The study is being funded by the European Commission as part of the European Medical Information Framework (EMIF), called EMIF-Metabolic. This research will help investigators to better predict who is likely to be at risk of developing diseases such as diabetes and to develop new medicines to prevent and treat these diseases. More details about EMIF-Metabolic are available here: http://www.emif.eu/emif-meta/objectives.
- Conditions
- Diabetes, Weight Gain, Weight Loss, Cardiovascular Disease, Obesity
- Being tested
- Weight gain, Weight loss
- Keywords
- diabetes, metabolism, cardiovascular disease, weight gain, weight loss, european, south asian, obesity
- Medical subject headings
- Diabetes Mellitus, Weight Gain, Weight Loss, Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight gainBehavioural
Weight gain of 7% body weight over 4-6 weeks by ingesting an extra 1500-2000 kcal/day
Weight lossBehavioural
Weight loss of 7-15% body weight over 12 weeks by increased exercise and either an alternate day fasting dietary regime or a weight watchers dietary regime
| Study group | Role | What they receive |
|---|---|---|
| South Asian participants | Other | 30 South Asian male participants Receives: Behavioral: Weight gain; Behavioral: Weight loss |
| European participants | Other | 30 European male participants Receives: Behavioral: Weight gain; Behavioral: Weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body metabolism after gaining 7% body weight and after losing 7% of body weight
Metabolic changes will be calculated by measuring levels of insulin, c-peptide, glucose, non-esterified fatty acids and NMR metabolomic responses to a standard 800 kcal meal tolerance test over 5 hours. Fasting serum adipokine levels will also be taken. Metabolic rate and substrate utilisation will be measured by indirect calorimetry using a ventilated hood.
Measured: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in visceral adipose tissue after gaining 7% body weight and after losing 7% body weight
Adipose tissue will be measured by MRI scanner and the change in visceral adipose tissue quantified
Measured: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in subcutaneous adipose tissue after gaining 7% body weight and after losing 7% body weight
Adipose tissue will be measured by MRI scanner and the change in subcutaneous adipose tissue quantified.
Measured: Weight gain assessment made after an expected average of 5 weeks and Weight loss assessment after 12 weeks
Change in liver adipose tissue after gaining 7% body weight and after losing 7% body weight
Liver adipose tissue will be measured by MRI spectroscopy and the change in liver adipose tissue quantified.
Measured: Weight gain assessment made after an expected average of 5 weeks and Weight loss assessment after 12 weeks
Change in adipose cell morphology after gaining 7% body weight and after losing 7% body weight.
Adipose cells will be obtained by needle biopsy from the subcutaneous layers of adipose tissue in the abdomen. Following this adipose cells will be assessed for their morphology including size and number.
Measured: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in adipose cell insulin sensitivity after gaining 7% body weight and after losing 7% body weight
Adipose cells will be obtained by needle biopsy from the subcutaneous layers of adipose tissue in the abdomen. Following this adipose cells will be assessed for their sensitivity to insulin.
Measured: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in adipose cell function after gaining 7% body weight and after losing 7% body weight
Adipose cells will be obtained by needle biopsy from the subcutaneous layers of adipose tissue in the abdomen. Following this adipose cells will be assessed for their cell function including gene expression markers related to triglyceride storage and differentiation of the cells.
Measured: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Secondary outcomes (6)
Change in fitness after gaining 7% body weight and after losing 7% of body weight
Fitness will be assessed by an incremental uphill treadmill walking protocol. Maximal oxygen uptake (VO2) max will then be calculated as a measure of fitness.
Measured: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in physical activity after gaining 7% body weight and after losing 7% of body weight
Physical activity will be measured objectively by accelerometer
Measured: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in dietary intake after gaining 7% body weight and after losing 7% of body weight
Dietary intake will be measured by weighed food record
Measured: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in facial appearance after gaining 7% body weight and after losing 7% of body weight
An additional optional component of the study is to have digital photographs taken which has been shown to correlate to health status. The photographs will be assessed by computer and analysed anonymously.
Measured: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in qualitative interviews after gaining 7% body weight and after losing 7% of body weight
An additional optional component of the study is qualitative interviews to assess body image, self-esteem and psychological wellbeing during the study.
Measured: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in cognition after gaining 7% body weight and after losing 7% of body weight
An additional option as part of the study is to assess cognition by means of a Sensitive Cognitive Assessment Inventory (SCAI) assessment tool. This involves a computer test which will assesses indices of cognitive function.
Measured: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study start11 Mar 2015
- Primary completion8 Mar 2018
- Study completion4 Jul 2018
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 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University, University of Pisa
- Responsible party
- Principal investigator, Professor Naveed Sattar, University of Glasgow
- Investigators
- Naveed Sattar, MD PhD, Principal investigator, Univesity of GlasgowJason MR Gill, PhD, Principal investigator, Univesity of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399423
- Sponsor's protocol ID
- Project number 60315/1
- Acronym
- GlasVEGAS
- Status last verified
- Sep 2023
- First submitted
- 12 Mar 2015
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Beazer JD, McLaren J, Christoffersen C, Ferraz MJ, Mulder MT, Graham D, Karlsson H, Ljunggren SA, Gill JMR, Freeman DJ. HDL protein composition differs between young white European and South Asian men before and after weight gain. Clin Sci (Lond). 2025 Dec 18;139(24):1659-74. doi: 10.1042/CS20258040.
PubMed 41416660McLaren J, Gao X, Ghouri N, Freeman DJ, Richardson J, Sattar N, Gill JMR. Weight gain leads to greater adverse metabolic responses in South Asian compared with white European men: the GlasVEGAS study. Nat Metab. 2024 Aug;6(8):1632-1645. doi: 10.1038/s42255-024-01101-z. Epub 2024 Aug 16.
PubMed 39152223
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GlasVEGAS Study (Glasgow Visceral & Ectopic Fat With Weight Gain in South AsianS) - Does Adipose Tissue Expandibility Differ Between South Asians and Europeans and Does This Contribute to Differences in Cardio-metabolic Disease Risk?
- ClinicalTrials.gov ID
- NCT02399423
- Acronym / sponsor ID
- GlasVEGAS / Project number 60315/1
- Conditions
- Diabetes, Weight Gain, Weight Loss, Cardiovascular Disease, Obesity
- Keywords
- diabetes, metabolism, cardiovascular disease, weight gain, weight loss, european, south asian, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Göteborg University, University of Pisa
- Study start
- 11 Mar 2015 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 26 Mar 2015 (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.
South Asians have a much higher risk of diabetes compared to Europeans and investigators don't know why this is. Investigators think that South Asians' capacity to store fat safely under the skin is lower than Europeans, so they start to store fat around internal organs and in liver and muscle, and at lower body weights than Europeans. These increased levels of internal fat storage are thought to increase risk of diabetes.
The purpose of the study therefore is to investigate whether there are differences with weight gain and weight loss in fat storage, fat cell function and metabolic risk factors, in South Asians compared with Europeans. Investigators will compare South Asian and European men at the start of the study, after they have gained about 7% body weight, and again after they have lost 7-15% body weight (from peak weight) to see how gaining and losing weight affects fat storage within the body and the function of fat cells. Investigators will also assess the effect of weight gain and weight loss on metabolism, fitness and risk factors for diabetes and heart disease.
Detailed description
South Asians have about five times the risk of adult onset diabetes (high blood sugar) than Europeans and nearly one in five South Asian men in the United Kingdom have the disease. Diabetes is a serious disease that can lead to a number of adverse health consequences including heart disease, kidney disease and blindness and accounts for about 10% of all healthcare costs in the UK. Obesity is strongly linked to diabetes risk, but the adverse effect of getting fatter on diabetes risk is much higher in South Asians than Europeans. The purpose of this study is to understand why this is the case. When humans put on weight initially this fat is stored under the skin (subcutaneous fat). This is relatively safe. However, when the capacity of this under skin storage is exceeded, fat is stored internally within the tummy area (visceral fat) and in organs such as the liver and muscle, which is less safe and increases diabetes risk. Investigators think that South Asians' capacity to store fat safely under the skin is lower than Europeans, so fat is stored internally and in liver and muscle at lower body weights than Europeans. The purpose of this study is to investigate whether this occurs and why. To do this investigators will compare a group of South Asian and European men and see how gaining and losing weight affects fat storage within the body and the function of fat cells. Investigators will also assess the effect of weight gain and weight loss on metabolism, fitness and risk factors for diabetes and heart disease.
The study will include healthy men of normal weight aged between 18-45 year and of either white European or South Asian (both parent of Indian, Pakistani, Bangladesh or Sri Lankan origin) ethnic origin.
Body weight will be altered by initially gaining weight and then losing weight. To do this participants will initially have to eat more food for 4-6 weeks and then go on a diet combined with exercise for 12 weeks. Participation in the study will last around 5½ months in total.
During the study pictures of body fat stores will be taken using an MRI scanner, a biopsy/sample of tummy fat will be taken to look at the fat cells and physical fitness and body metabolism (the way the body deals with sugar, insulin and fat) will be measured. These measurements will be done at three different times: before gaining weight, once weight is gained, and after losing weight (and back to original weight). The measurements will give a detailed assessment of the changes in the body when gaining or losing weight.
The benefits of taking part in the study are receiving detailed feedback about fitness levels, body fat, dietary intake, blood pressure, cholesterol, blood sugar and level of "insulin resistance". Feedback about the overall study findings will also be provided.
In addition, the knowledge gained from participation may benefit people who are at risk of diabetes in the future by increasing our understanding of why South Asians are at increased risk of developing diabetes. It will also help guide future research investigating how to reduce this increased risk through lifestyle changes and may also help direct the development of medicines to prevent and treat diabetes groups at increased risk of the disease.
Possible disadvantages of the study are gaining 7% of body weight over 4-6 weeks. This is likely to temporarily induce negative metabolic changes. However, investigators are also supporting losing this weight (and hopefully more) in the weight loss phase of the study. There is no evidence that short-term weight gain of this nature causes any long-term adverse effects. Longer-term weight gain however is associated with an increased risk of diabetes, cardiovascular disease and high blood pressure. It is therefore important that investigators ensure participants return to original weight at the start of the study. Taking fat biopsies carries a small risk of minor bruising or an infection. Good sterile practice reduces this risk of infection and application of ice and pressure to the biopsy site reduces the risk of bruising. Blood sampling via the cannula may cause minor bruising or an inflammation of the vein. Some participants may feel faint when they give blood. One of the exercise tests will be at a maximal level and the possibility exists that, very occasionally, certain changes may occur during or shortly after the test. They include abnormal blood pressure, fainting or a change in the normal rhythm of the heartbeat. There is a small possibility that taking part in this study will reveal a health problem that patients already have such as high cholesterol or high blood pressure. If such a problem is revealed, investigators will ask permission to inform the participant's General Practitioner to receive clinically appropriate follow-up care.
This study is running for ~2.5 years from March 2015 and is based at the University of Glasgow. The study is being funded by the European Commission as part of the European Medical Information Framework (EMIF), called EMIF-Metabolic. This research will help investigators to better predict who is likely to be at risk of developing diseases such as diabetes and to develop new medicines to prevent and treat these diseases. More details about EMIF-Metabolic are available here: http://www.emif.eu/emif-meta/objectives.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| South Asian participants | Other | Behavioral: Weight gain, Behavioral: Weight loss30 South Asian male participants |
| European participants | Other | Behavioral: Weight gain, Behavioral: Weight loss30 European male participants |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants will be men of European (self-report of both parents of white European origin) or South Asian (self-report of both parents of Indian, Pakistani, Bangladeshi or Sri Lankan origin) with BMI <25 kg.m-2, who have been weight stable (± 2 kg) for >6 months.
Key exclusion criteria (1 listed)
- Exclusion criteria will include diabetes (physician diagnosed or HbA1c ≥6.5% on screening), history of cardiovascular disease, regular participation in vigorous physical activity, current smoking, taking drugs or supplements thought to affect carbohydrate or lipid metabolism, or other significant illness that would prevent full participation in the study.
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 |
|---|---|---|
| Weight gainWeight gain of 7% body weight over 4-6 weeks by ingesting an extra 1500-2000 kcal/day | Behavioural | European participants, South Asian participants |
| Weight lossWeight loss of 7-15% body weight over 12 weeks by increased exercise and either an alternate day fasting dietary regime or a weight watchers dietary regime | Behavioural | European participants, South Asian participants |
Primary outcome
Change in body metabolism after gaining 7% body weight and after losing 7% of body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Metabolic changes will be calculated by measuring levels of insulin, c-peptide, glucose, non-esterified fatty acids and NMR metabolomic responses to a standard 800 kcal meal tolerance test over 5 hours. Fasting serum adipokine levels will also be taken. Metabolic rate and substrate utilisation will be measured by indirect calorimetry using a ventilated hood.
Change in visceral adipose tissue after gaining 7% body weight and after losing 7% body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Adipose tissue will be measured by MRI scanner and the change in visceral adipose tissue quantified
Change in subcutaneous adipose tissue after gaining 7% body weight and after losing 7% body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and Weight loss assessment after 12 weeks
Adipose tissue will be measured by MRI scanner and the change in subcutaneous adipose tissue quantified.
Change in liver adipose tissue after gaining 7% body weight and after losing 7% body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and Weight loss assessment after 12 weeks
Liver adipose tissue will be measured by MRI spectroscopy and the change in liver adipose tissue quantified.
Change in adipose cell morphology after gaining 7% body weight and after losing 7% body weight.
Time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Adipose cells will be obtained by needle biopsy from the subcutaneous layers of adipose tissue in the abdomen. Following this adipose cells will be assessed for their morphology including size and number.
Change in adipose cell insulin sensitivity after gaining 7% body weight and after losing 7% body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Adipose cells will be obtained by needle biopsy from the subcutaneous layers of adipose tissue in the abdomen. Following this adipose cells will be assessed for their sensitivity to insulin.
Change in adipose cell function after gaining 7% body weight and after losing 7% body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Adipose cells will be obtained by needle biopsy from the subcutaneous layers of adipose tissue in the abdomen. Following this adipose cells will be assessed for their cell function including gene expression markers related to triglyceride storage and differentiation of the cells.
6 secondary outcomes
Change in fitness after gaining 7% body weight and after losing 7% of body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in physical activity after gaining 7% body weight and after losing 7% of body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in dietary intake after gaining 7% body weight and after losing 7% of body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in facial appearance after gaining 7% body weight and after losing 7% of body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in qualitative interviews after gaining 7% body weight and after losing 7% of body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Change in cognition after gaining 7% body weight and after losing 7% of body weight
Time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
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 18 Sep 2023.
- Derived from this study: PubMed 41416660Beazer JD, McLaren J, Christoffersen C, Ferraz MJ, Mulder MT, Graham D, Karlsson H, Ljunggren SA, Gill JMR, Freeman DJ. HDL protein composition differs between young white European and South Asian men before and after weight gain. Clin Sci (Lond). 2025 Dec 18;139(24):1659-74. doi: 10.1042/CS20258040.
- Derived from this study: PubMed 39152223McLaren J, Gao X, Ghouri N, Freeman DJ, Richardson J, Sattar N, Gill JMR. Weight gain leads to greater adverse metabolic responses in South Asian compared with white European men: the GlasVEGAS study. Nat Metab. 2024 Aug;6(8):1632-1645. doi: 10.1038/s42255-024-01101-z. Epub 2024 Aug 16.
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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.
Naveed Sattar, MD PhD principal investigator
Univesity of Glasgow
Jason MR Gill, PhD principal investigator
Univesity of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight gain and Weight loss in people with Diabetes and Weight Gain, run by University of Glasgow at 1 site in United Kingdom.
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 1 inclusion and 1 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 18 Sep 2023. 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 Kingdom. 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?
Change in body metabolism after gaining 7% body weight and after losing 7% of body weight (time frame: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks). The study lists 7 primary outcomes in all. 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 NCT02399423, 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 18 Sep 2023.