NCT02399423

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2018

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

March 12, 2015

Last Update Submit

September 15, 2023

Conditions

DiabetesWeight GainWeight LossCardiovascular DiseaseObesity

Keywords

diabetesmetabolismcardiovascular diseaseweight gainweight losseuropeansouth asianobesity

Outcome Measures

Primary Outcomes (7)

  • 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.

    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

    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.

    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.

    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.

    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.

    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.

    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

    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

    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

    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

    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

    Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

South Asian participants

OTHER

30 South Asian male participants

Behavioral: Weight gainBehavioral: Weight loss

European participants

OTHER

30 European male participants

Behavioral: Weight gainBehavioral: Weight loss

Interventions

Weight gainBEHAVIORAL

Weight gain of 7% body weight over 4-6 weeks by ingesting an extra 1500-2000 kcal/day

European participantsSouth Asian participants
Weight lossBEHAVIORAL

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

European participantsSouth Asian participants

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, G12 8TA, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 41416660DERIVED

  • McLaren 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.

    PMID: 39152223DERIVED

MeSH Terms

Conditions

Diabetes MellitusWeight GainWeight LossCardiovascular DiseasesObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition Disorders

Study Officials

  • Naveed Sattar, MD PhD

    Univesity of Glasgow

    PRINCIPAL INVESTIGATOR

  • Jason MR Gill, PhD

    Univesity of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Metabolic medicine

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 26, 2015

Study Start

March 11, 2015

Primary Completion

March 8, 2018

Study Completion

July 4, 2018

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations

GB(1)