Brief Summary

Whilst there is an increasing prevalence of overweight and obesity worldwide, malnutrition remains common. In addition, malnutrition, overweight, and infections often interact. The consequences of malnutrition after birth are little studied. Severe acute malnutrition in childhood remains common in Africa and Asia and many adult patients with tuberculosis or HIV, diseases which are common in Africa and Asia, may become malnourished. The investigators are interested in diabetes, which in Africa and Asia affects people at younger age and lower weight than in Europe. There is evidence that severe postnatal malnutrition increases the risk of later diabetes but the evidence is piecemeal and there is little information as to the mechanisms involved. It is thus difficult to determine what treatments or preventative strategies are appropriate. The investigators wish to focus on the pancreas which is a key organ in digestion and metabolic processes, especially in relation to diabetes. They will investigate pancreas size, microscopic structure, hormone and digestive enzyme production, and the body's response to these hormones among groups of people in Tanzania, Zambia, India and the Philippines. These groups have participated in the research team's previous studies of malnutrition and were malnourished before birth, as children, or as adults. They now live in places with a wide range of access to foods high in fat and sugar which could affect their risk of diabetes. The investigators will compare their pancreas function to that of never-malnourished controls at each site. The investigators will use advanced statistical methods to understand the links between early malnutrition and later diabetes, taking into account the factors often associated with diabetes such as age, current overweight and infection. Even if the investigators find no important link between early malnutrition and later diabetes, the research will lead to improved understanding of the long-term consequences of malnutrition and the presentation and underlying metabolism of diabetes in Africa and Asia. Thus, the project will lead to improved health care for both malnourished and diabetic people.

Trial Health

On Track

Trial Health Score

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

Enrollment

2,305

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach

4 countries

4 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.6 years study duration

Study Start

First participant enrolled

January 12, 2021

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed

9 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed

Last Updated

April 27, 2025

Status Verified

October 1, 2024

Enrollment Period

2.6 years

First QC Date

April 25, 2022

Last Update Submit

April 23, 2025

Conditions

Pancreas Atrophy Diabetes Malnutrition

Keywords

diabetesexocrine pancreasendocrine pancreasmalnutrition

Outcome Measures

Primary Outcomes (2)

Pancreas endocrine function
Mathematical modelling of blood glucose, insulin and C-peptide at 3 (for children) or 7 (for adults) times during a 120 minute oral glucose tolerance test (OGTT) to determine first and second phase insulin release and insulin resistance
1 year
Pancreas exocrine function
faecal elastase and plasma lipase
1 year

Secondary Outcomes (7)

Pancreas size and structure
1 year
pancreatic calcification
1 year
Hemoglobin A1c
1 year
insulin production and insulin resistance (in-depth study in a subset)
1 year
gastrointestinal contribution to glucose metabolism and diabetes
1 year
+2 more secondary outcomes

Study Arms (6)

DIVIDS (Delhi Infant Vitamin D Supplementation) study, India

The DIVIDS cohort were born low birth weight (LBW, \<2.5 kg) at term in 2007-2010. They had monthly follow-up until 6m then at 5 and 11 years. Anthropometry was collected at all visits, body composition in the 5 and 11 years, and blood samples at 6 months and 5 and 11 years. For SAMPA, the DIVIDS cohort acts as a positive control since we expect adverse long-term non-communicable disease consequences of being born LBW. Sample numbers at previous follow-ups and expected: * Birth: 2079 total, all LBW * Age 5 y: 911 total, 764 (84%) BMIZ\>-2, 138 (15%) BMIZ -2 to -3, 9 (1%) BMIZ\<-3 * Age 11 y (ongoing): 647 total, 482 (75%) BMIZ\>-2, 117 (18%) BMIZ -2 to -3, 48 (7%) BMIZ\<-3 * Expected for SAMPA: 800 total